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OrphoMed is looking for IBS-D patients suffering pain and diarrhea

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#1 Robert_Larsson

Robert_Larsson

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Posted 10 December 2019 - 08:21 AM

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Orphomed is currently developing a new medication for IBS-D and is looking for patients who would like to participate in their Phase 2 Clinical Trial.

 

ORP-101 as the medication is called, works by slowing down the intestinal transit while simultaneously easing abdominal pain. The ongoing Phase 2 study is looking for IBS-D patients between 18 to 75 years old, who will receive either 50mg, 100mg or placebo during the 12 week enrolment period. The study will enroll about 320 patients across the entire USA and will measure both pain scores and stool consistency. Because of its promise ORP-101 received the FDA Fast Track Designation in April 2018.

 

If you would like to read more about this new medication visit the Orphomed website, or check out their latest presentation.

 

To participate in this Phase 2 study (NCT04129619) register here, or follow the instructions below where you will also find all study locations recruiting.

 

The Study can be found here: http://prevailibsdstudy.com/

 

 

Contacts:

 

Contact: Sowmya Krishnamurthy Please email:

[email protected]

 

Contact: Lynsey Nagrani Please email:

[email protected]

 

 

Locations


United States, Alabama

Achieve Clinical Research (Site 155)

Birmingham, Alabama, United States, 35216

Contact: If interested in participating at this site, enter NCT 04129619 and Site 155 in subject line of email, and send to       [email protected]  

 

United States, Arizona

Synexus Clinical Research US, Inc. - Phoenix Southeast (Site 123)

Chandler, Arizona, United States, 85224

Contact: If interested in participating at this site, enter NCT 04129619 and Site 123 in subject line of email, and send to       [email protected]   


Elite Clinical Studies - Phoenix (Site 116)

Phoenix, Arizona, United States, 85018

Contact: If interested in participating at this site, enter NCT 04129619 and Site 116 in subject line of email, and send to       [email protected]   


Del Sol Research Management - BTC - PPDS (Site 165)

Tucson, Arizona, United States, 85712

Contact: If interested in participating at this site, enter NCT 04129619 and Site 165 in subject line of email, and send to       [email protected]  

 

Synexus Clinical Research US, Inc. - Orange Grove Family Practice (Site 118)

Tucson, Arizona, United States, 85741

Contact: If interested in participating at this site, enter NCT 04129619 and Site 118 in subject line of email, and send to       [email protected] 

  

Del Sol Research Management - BTC - PPDS (Site 130)

Tucson, Arizona, United States, 85745

Contact: If interested in participating at this site, enter NCT 04129619 and Site 130 in subject line of email, and send to       [email protected]   


United States, Arkansas

Preferred Research Partners - ClinEdge - PPDS (Site 103)

Little Rock, Arkansas, United States, 72211

Contact: If interested in participating at this site, enter NCT 04129619 and Site 103 in subject line of email, and send to       [email protected]   


Applied Research Center (Site 158)

Little Rock, Arkansas, United States, 72212

Contact: If interested in participating at this site, enter NCT 04129619 and Site 158 in subject line of email, and send to       [email protected]   


United States, Connecticut

Connecticut Clinical Research Foundation (Site 136)

Bristol, Connecticut, United States, 06010

Contact: If interested in participating at this site, enter NCT 04129619 and Site 136 in subject line of email, and send to       [email protected]   


United States, Florida

Meridien Research - Lakeland - PPDS (Site 167)

Lakeland, Florida, United States, 33803

Contact: If interested in participating at this site, enter NCT 04129619 and Site 167 in subject line of email, and send to       [email protected]   


Precision Clinical Research LLC (Site 139)

Lauderdale Lakes, Florida, United States, 33319

Contact: If interested in participating at this site, enter NCT 04129619 and Site 139 in subject line of email, and send to       [email protected]   


Meridien Research, Maitland -Inpatient (Site 141)

Maitland, Florida, United States, 32751

Contact: If interested in participating at this site, enter NCT 04129619 and Site 141 in subject line of email, and send to       [email protected]   


Oviedo Medical Research (Site 140)

Oviedo, Florida, United States, 32765

Contact: If interested in participating at this site, enter NCT 04129619 and Site 140 in subject line of email, and send to       [email protected]   


Meridien Research - St. Petersburg - PPDS (Site 132)

Saint Petersburg, Florida, United States, 33709

Contact: If interested in participating at this site, enter NCT 04129619 and Site 132 in subject line of email, and send to       [email protected]   


United States, Georgia

Agile Clinical Research Trials, LLC (Site 163)

Atlanta, Georgia, United States, 30328

Contact: If interested in participating at this site, enter NCT 04129619 and Site 163 in subject line of email, and send to       [email protected]   


Gastrointestinal Diseases, Inc. Research (Site 137)

Columbus, Georgia, United States, 31904

Contact: If interested in participating at this site, enter NCT 04129619 and Site 137 in subject line of email, and send to       [email protected]   


In Quest Medical Research (Site 131)

Peachtree Corners, Georgia, United States, 30071

Contact: If interested in participating at this site, enter NCT 04129619 and Site 131 in subject line of email, and send to       [email protected]  

 

Meridian Clinical Research-(Savannah Georgia) (Site 169)

Savannah, Georgia, United States, 31401

Contact: If interested in participating at this site, enter NCT 04129619 and Site 169 in subject line of email, and send to       [email protected]   


GNP Research (Site 145)

Valdosta, Georgia, United States, 31605

Contact: If interested in participating at this site, enter NCT 04129619 and Site 145 in subject line of email, and send to       [email protected] 

  

United States, Idaho

Northwest Clinical Trials - ClinEdge - PPDS (Site 133)

Boise, Idaho, United States, 83704

Contact: If interested in participating at this site, enter NCT 04129619 and Site 133 in subject line of email, and send to       [email protected]   


United States, Illinois

Synexus Clinical Research US, Inc. - Chicago (Site 120)

Chicago, Illinois, United States, 60602

Contact: If interested in participating at this site, enter NCT 04129619 and Site 120 in subject line of email, and send to       [email protected]   


United States, Indiana

Synexus Clinical Research US, Inc. - Allaw (Site 102)

Evansville, Indiana, United States, 47714

Contact: If interested in participating at this site, enter NCT 04129619 and Site 102 in subject line of email, and send to       [email protected]   


United States, Kansas

Heartland Research Associates, LLC (Site 170)

Newton, Kansas, United States, 67114

Contact: If interested in participating at this site, enter NCT 04129619 and Site 170 in subject line of email, and send to       [email protected]  

 

Alliance for Multispecialty Research, LLC (Site 159)

Wichita, Kansas, United States, 67207

Contact: If interested in participating at this site, enter NCT 04129619 and Site 159 in subject line of email, and send to       [email protected]   


United States, Massachusetts

Beth Israel Deaconess Medical Center (Site 115)

Boston, Massachusetts, United States, 02215

Contact: If interested in participating at this site, enter NCT 04129619 and Site 115 in subject line of email, and send to       [email protected]   


United States, Minnesota

Synexus Clinical Research US, Inc. - Minneapolis (Site 114)

Richfield, Minnesota, United States, 55432

Contact: If interested in participating at this site, enter NCT 04129619 and Site 114 in subject line of email, and send to       [email protected]   


United States, Nebraska

Synexus Clinical Research US, Inc. - Omaha (Site 113)

Omaha, Nebraska, United States, 68144

Contact: If interested in participating at this site, enter NCT 04129619 and Site 113 in subject line of email, and send to       [email protected] 

  

Synexus Clinical Research US, Inc. - McGill Family Practice, P.C. (Site 126)

Papillion, Nebraska, United States, 68046

Contact: If interested in participating at this site, enter NCT 04129619 and Site 126 in subject line of email, and send to       [email protected]   


United States, Nevada

Jubilee Clinical Research - BTC - PPDS (Site 162)

Las Vegas, Nevada, United States, 89106

Contact: If interested in participating at this site, enter NCT 04129619 and Site 162 in subject line of email, and send to       [email protected]   


United States, New York

NY Scientific (Site 153)

Brooklyn, New York, United States, 11235

Contact: If interested in participating at this site, enter NCT 04129619 and Site 153 in subject line of email, and send to       [email protected]   


Long Island Gastrointestinal Research Group LLP (Site 107)

Great Neck, New York, United States, 11023

Contact: If interested in participating at this site, enter NCT 04129619 and Site 107 in subject line of email, and send to       [email protected]   


Synexus Clinical Research US, Inc. - Queens (Site 119)

Jamaica, New York, United States, 11432

Contact: If interested in participating at this site, enter NCT 04129619 and Site 119 in subject line of email, and send to       [email protected]   


Circuit Clinical (Site 161)

Orchard Park, New York, United States, 14127

Contact: If interested in participating at this site, enter NCT 04129619 and Site 161 in subject line of email, and send to       [email protected]   


Upstate Clinical Research Associates LLC - ClinEdge - PPDS (Site 164)

Williamsville, New York, United States, 14221

Contact: If interested in participating at this site, enter NCT 04129619 and Site 164 in subject line of email, and send to       [email protected]   


United States, North Carolina

OnSite Clinical Solutions, LLC - ClinEdge - PPDS (Site 147)

Charlotte, North Carolina, United States, 28210

Contact: If interested in participating at this site, enter NCT 04129619 and Site 147 in subject line of email, and send to       [email protected]   


OnSite Clinical Solutions, LLC - ClinEdge - PPDS (Site 146)

Charlotte, North Carolina, United States, 28277

Contact: If interested in participating at this site, enter NCT 04129619 and Site 146 in subject line of email, and send to       [email protected]   


Peters Medical Research, LLC - ClinEdge - PPDS (SIte 111)

High Point, North Carolina, United States, 27262

Contact: If interested in participating at this site, enter NCT 04129619 and Site 111 in subject line of email, and send to       [email protected] 

  

PMG Research of Salisbury LLC (Site 110)

Salisbury, North Carolina, United States, 28144

Contact: If interested in participating at this site, enter NCT 04129619 and Site 110 in subject line of email, and send to       [email protected]   


PMG Research of Winston-Salem (Site 124)

Winston-Salem, North Carolina, United States, 27103

Contact: If interested in participating at this site, enter NCT 04129619 and Site 124 in subject line of email, and send to       [email protected]   


United States, Ohio

Synexus Clinical Research US, Inc. - Akron (Site 122)

Akron, Ohio, United States, 44311

Contact: If interested in participating at this site, enter NCT 04129619 and Site 122 in subject line of email, and send to       [email protected]  

 

Hometown Urgent Care and Research (Site 150)

Cincinnati, Ohio, United States, 45215

Contact: If interested in participating at this site, enter NCT 04129619 and Site 150 in subject line of email, and send to       [email protected]   

Synexus Clinical Research US, Inc. - Cincinnati (Site 127)

Cincinnati, Ohio, United States, 45236

Contact: If interested in participating at this site, enter NCT 04129619 and Site 127 in subject line of email, and send to       [email protected]   


Synexus Clinical Research US, Inc. - Columbus (Site 108)

Columbus, Ohio, United States, 43212

Contact: If interested in participating at this site, enter NCT 04129619 and Site 108 in subject line of email, and send to       [email protected]   


Hometown Urgent Care and Research (Site 149)

Columbus, Ohio, United States, 43214

Contact: If interested in participating at this site, enter NCT 04129619 and Site 149 in subject line of email, and send to       [email protected]   


Remington Davis Inc (Site 144)

Columbus, Ohio, United States, 43215

Contact: If interested in participating at this site, enter NCT 04129619 and Site 144 in subject line of email, and send to       [email protected]   


PriMed Clinical Research - ClinEdge - PPDS (Site 121)

Dayton, Ohio, United States, 45419

Contact: If interested in participating at this site, enter NCT 04129619 and Site 121 in subject line of email, and send to       [email protected]   


Hometown Urgent Care and Research (Site 151)

Dayton, Ohio, United States, 45424

Contact: If interested in participating at this site, enter NCT 04129619 and Site 151 in subject line of email, and send to       [email protected]   


United States, Pennsylvania

Tristar Clinical Investigations, P.C. (Site 168)

Philadelphia, Pennsylvania, United States, 19114

Contact: If interested in participating at this site, enter NCT 04129619 and Site 168 in subject line of email, and send to       [email protected]   


Frontier Clinical Research, LLC (Site 171)

Uniontown, Pennsylvania, United States, 15401

Contact: If interested in participating at this site, enter NCT 04129619 and Site 171 in subject line of email, and send to       [email protected]   


United States, South Carolina

Piedmont Research Partners LLC - BTC - PPDS (Site 157)

Fort Mill, South Carolina, United States, 29707

Contact: If interested in participating at this site, enter NCT 04129619 and Site 157 in subject line of email, and send to       [email protected]   


Synexus clinical Research US, Inc. - Greer (Site 105)

Greer, South Carolina, United States, 29651

Contact: If interested in participating at this site, enter NCT 04129619 and Site 105 in subject line of email, and send to       [email protected]   


United States, South Dakota

Meridian Clinical Research-(Dakota Dunes-South Dakota) (Site 160)

Dakota Dunes, South Dakota, United States, 57049

Contact: If interested in participating at this site, enter NCT 04129619 and Site 160 in subject line of email, and send to       [email protected]   


United States, Tennessee

WR-ClinSearch, LLC (Site 129)

Chattanooga, Tennessee, United States, 37421

Contact: If interested in participating at this site, enter NCT 04129619 and Site 129 in subject line of email, and send to       [email protected]   


The Jackson Clinic PA - ClinEdge - PPDS (Site 135)

Jackson, Tennessee, United States, 38305

Contact: If interested in participating at this site, enter NCT 04129619 and Site 135 in subject line of email, and send to       [email protected]  

 

United States, Texas

Advanced Medical Trials (SIte 142)

Georgetown, Texas, United States, 78628

Contact: If interested in participating at this site, enter NCT 04129619 and Site 142 in subject line of email, and send to       [email protected]   


University of Texas Health Science Center at Houston (Site 128)

Houston, Texas, United States, 77030

Contact: If interested in participating at this site, enter NCT 04129619 and Site 128 in subject line of email, and send to       [email protected]   


Pioneer Research Solutions (Site 125)

Houston, Texas, United States, 77099

Contact: If interested in participating at this site, enter NCT 04129619 and Site 125 in subject line of email, and send to       [email protected]   


Discovery MM Services Incorporated - Missouri City - Hunt - PPDS (Site 156)

Missouri City, Texas, United States, 77459

Contact: If interested in participating at this site, enter NCT 04129619 and Site 156 in subject line of email, and send to       [email protected]   


DM Clinical Research - LinQ Research - ERN - PPDS (Site 109)

Pearland, Texas, United States, 77584

Contact: If interested in participating at this site, enter NCT 04129619 and Site 109 in subject line of email, and send to       [email protected]   


Synexus Clinical Research US, Inc. - San Antonio (Site 112)

San Antonio, Texas, United States, 48229

Contact: If interested in participating at this site, enter NCT 04129619 and Site 112 in subject line of email, and send to       [email protected]   


Clinical Trials of Texas Incorporated - ClinEdge - PPDS (Site 134)

San Antonio, Texas, United States, 78229

Contact: If interested in participating at this site, enter NCT 04129619 and Site 134 in subject line of email, and send to       [email protected]   


United States, Utah

Synexus Clinical Research US, Inc. - Salt Lake City (Site 101)

Murray, Utah, United States, 84123

Contact: If interested in participating at this site, enter NCT 0412961 and Site 101 in subject line of email, and send to       [email protected]   


Advanced Research Institute (Site 117)

Ogden, Utah, United States, 84405

Contact: If interested in participating at this site, enter NCT 04129619 and Site 117 in subject line of email, and send to       [email protected] 

  

United States, Virginia

The Center of Gastrointestinal Health (Site 152)

Petersburg, Virginia, United States, 23805

Contact: If interested in participating at this site, enter NCT 04129619 and Site 152 in subject line of email, and send to       [email protected]  

 

United States, Washington

Northwest Clinical Research Center - ClinEdge - PPDS (Site 148)

Bellevue, Washington, United States, 98007

Contact: If interested in participating at this site, enter NCT 04129619 and Site 148 in subject line of email, and send to       [email protected]  

 

United States, West Virginia

Exemplar Research, Inc. - Morgantown (Site 172)

Morgantown, West Virginia, United States, 26505

Contact: If interested in participating at this site, enter NCT 04129619 and Site 172 in subject line of email, and send to       [email protected]  

 

 

About ORP-101

The mechanism of action of ORP-101 is described as a partial mu-opioid agonist for motility control, a well established mechanism used in many anti-diarrheal medications to slow peristalsis and increase water absorption to combat symptoms of diarrhea, and a full kappa-opioid antagonist which serves as a potent anti-hyperalgesic by regulating nociception. Since it is peripherally restricted while being both metabolically and chemically stable, ORP-101 does not enter the central nervous system and thus has no abuse potential which has been demonstrated in Phase 1 Human safety trials and preclinical toxicology studies.

 

As most of you are probably aware of the Opioid Crisis in the U.S., the FDA is looking to bring forward new non-narcotic and non-addictive alternatives for patients. Because of its promise for IBS-D patients, ORP-101 received the Fast Track Designation in April 2018.

 

As of December 2018 six well known IBS experts have participated in the design of this Phase 2 study, read the press release here: https://www.orphomed...ses/2018-12-18/

 

Hope this is useful to some of you out there, take care! -Robert



#2 Robert_Larsson

Robert_Larsson

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Posted 07 January 2020 - 09:34 PM

This press release was issued by OrphoMed today: https://www.orphomed...ses/2020-01-07/

 

OrphoMed Initiates U.S. Phase 2 Adaptive Design Study of ORP-101 for Treatment of IBS-D

—Interim Assessment Anticipated in Second Half of 2020—

January 7, 2020

SAN FRANCISCO, CA– OrphoMed, Inc., a clinical-stage biopharmaceutical company developing first-in-class dimer therapeutics, today announced initiation of its PREVAIL trial, a Phase 2 response-adaptive clinical study of ORP-101, a peripherally-acting buprenorphine dimer for the treatment of irritable bowel syndrome with diarrhea (IBS-D). The study is designed to assess safety and efficacy of ORP-101 compared to placebo and includes two pre-defined interim analyses, both of which are anticipated in the second half of 2020.

Principal Investigator Dr. Anthony Lembo stated, “ORP-101 has the potential to become an important therapy for the treatment of IBS-D. It could have a significant impact on patients’ health and quality of life.”

About ORP-101

ORP-101 is a new chemical entity designed with intent to create a large stable molecule and to confer partial μ agonist and full κ-antagonist receptor pharmacology. 
Key highlights:

  • ORP-101 has been shown in preclinical studies to not cross the blood-brain barrier.
  • ORP-101 successfully completed Phase 1 and was granted FDA Fast Track designation in 2018. Regulatory path to NDA has been agreed with the FDA.
  • ORP-101 Phase 2 currently enrolling, utilizing adaptive 3-month treatment design powered for Phase 3 predictive outcomes.
About the PREVAIL Trial

The PREVAIL study, now enrolling patients, is a multi-center, double-blind, placebo-controlled, response-adaptive randomization study to evaluate the safety and efficacy of ORP-101 in approximately 320 patients with IBS-D. Study participants will be randomized to receive one of two different doses of ORP-101 tablets or placebo for 12 weeks. The primary endpoint is percentage of patients who are composite responders, based on improvements from baseline in daily worst abdominal pain and daily stool consistency scores. Secondary endpoints include percentage of participants who are responders in the following assessments: daily worst abdominal pain, daily stool consistency, IBS global symptom, IBS adequate relief, modified composite response, daily abdominal discomfort, daily abdominal bloating, number of bowel movements per day, and number of bowel incontinence-free days.

The study includes two interim analyses at enrollment of 200 and 260 patients, respectively, conducted by a third party to evaluate (1) dose response and patient allocation using a response-adaptive randomization and (2) stopping accrual early for sufficient efficacy or futility. OrphoMed expects to conduct the interim analyses in the second half of 2020. Topline results are expected in the first half of 2021.







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