Clinical trial NCT03931785: A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Study of MD-7246 Administered Orally for 12 Weeks to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome With Diarrhea (IBS-D)
Keywords: Abdominal pain
Diarrhea
Irritable Bowel Syndrome
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Allergan Sales, LLC
First posted: 2019-04-30
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability, treatment effect on abdominal pain, and dose response of MD-7246 administered orally to patients with diarrhea-predominant irritable bowel syndrome (IBS-D).


Eligibility criteria: Inclusion Criteria:

* Patient meets the Rome IV criteria for diagnosis of IBS-D
* Patient maintains a minimum level of compliance with daily diary
* Female patients of childbearing potential must agree to use one of the following methods of birth control:

  1. Hormonal contraception
  2. Double-barrier method
  3. Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy

Exclusion Criteria:

* Patient has clinically significant findings on a physical examination and/or clinical laboratory tests
* Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
* Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
* Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments

NOTE: Additional inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period
timeFrame: Baseline, up to Week 12 (end of the Treatment Period)
measure: Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders
timeFrame: Baseline through Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clinical Research Associates
state: Alabama
city: Phoenix
country: United States
facility: Elite Clinical Studies
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Chula Vista
country: United States
facility: GW Research, Inc.
state: California
city: Corona
country: United States
facility: Kindred Medical Institute for Clinical Trials, LLC
state: California
city: Encinitas
country: United States
facility: Diagnamics Inc.
state: California
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Garden Grove
country: United States
facility: Paragon Rx Clinical
state: California
city: La Mesa
country: United States
facility: Grossmont Center For Clinical Research
state: California
city: Mission Hills
country: United States
facility: Facey Medical Foundation
state: California
city: North Hollywood
country: United States
facility: Providence Clinical Research
state: California
city: San Diego
country: United States
facility: Precision Research Institute
state: California
city: Santa Ana
country: United States
facility: Paragon Rx Clinical, Inc. - Santa Ana
state: California
city: Sherman Oaks
country: United States
facility: UNISON Clinical Trials
state: California
city: Thousand Oaks
country: United States
facility: Millennium Clinical Trials
state: California
city: Westminster
country: United States
facility: Advanced Rx Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Bristol
country: United States
facility: Connecticut Clinical Research Institute
state: Connecticut
city: Hamden
country: United States
facility: Chase Medical Research of Greater New Haven LLC
state: Connecticut
city: Kissimmee
country: United States
facility: The Chappel Group Research, LLC
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic Inc
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research Corporation
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Ormond Beach
country: United States
facility: Ormond Medical Arts Pharmaceutical Research Center
state: Florida
city: Saint Petersburg
country: United States
facility: Meridien Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Winter Park
country: United States
facility: Research Institute of Central Florida, LLC
state: Florida
city: Sandy Springs
country: United States
facility: Mount Vernon Clinical Research, LLC
state: Georgia
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates LTD
state: Illinois
city: Metairie
country: United States
facility: Clinical Trials Management LLC
state: Louisiana
city: West Monroe
country: United States
facility: Clinical Trials of America -- LA LLC
state: Louisiana
city: Hagerstown
country: United States
facility: Meritus Center For Clinical Research
state: Maryland
city: Rockville
country: United States
facility: Meridian Clinical Research
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials Inc
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Fall River
country: United States
facility: New England Center For Clinical Research Inc PrimaCare Research, LLC
state: Massachusetts
city: Watertown
country: United States
facility: MedVadis Research Corporation
state: Massachusetts
city: Chesterfield
country: United States
facility: Galen Research
state: Missouri
city: Bozeman
country: United States
facility: Bozeman Health Deaconess Hospital
state: Montana
city: La Vista
country: United States
facility: Barrett Clinic, P.C. - BTC - PPDS
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research of South Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Advanced Biomedical Research of America
state: Nevada
city: Brooklyn
country: United States
facility: Healthwise Medical Associates
state: New York
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group LLP
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Charlotte
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Concord
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research, LLC
state: North Carolina
city: Mount Airy
country: United States
facility: Clinical Trials of America-NC, LLC
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Winston-Salem
country: United States
facility: Progressive Medicine of the Triad, LLC
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Cincinnati
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Cincinnati
country: United States
facility: Hightop Medical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: New Horizons Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Columbus
country: United States
facility: Remington Davis Inc
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Oklahoma City
country: United States
facility: IPS Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: Digestive Disease Specialists, Inc.
state: Oklahoma
city: Salem
country: United States
facility: Oregon Center For Clinical Investigations Inc
state: Oregon
city: Cumberland
country: United States
facility: Partners In Clinical Research
state: Rhode Island
city: Lincoln
country: United States
facility: Ocean State Clinical Research Partners
state: Rhode Island
city: Greer
country: United States
facility: Mountain View Clinical Research Inc
state: South Carolina
city: Chattanooga
country: United States
facility: WR-ClinSearch, LLC
state: Tennessee
city: Knoxville
country: United States
facility: New Phase Research & Development
state: Tennessee
city: Beaumont
country: United States
facility: MW Clinical Research Center
state: Texas
city: El Paso
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: San Antonio
country: United States
facility: DCT - Stone Oak, LLC dba Discovery Clinical Trials
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Christiansburg
country: United States
facility: New River Valley Research Institute
state: Virginia
Study officials:
affiliation: Ironwood Pharmaceuticals, Inc.
name: Wilmin Bartolini, PhD
role: STUDY_CHAIR
References: