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A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome With Diarrhea (IBS-D)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MD-7246
Placebo
Sponsored by
Ironwood Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Diarrhea (IBS-D) focused on measuring Abdominal pain, Diarrhea, Irritable Bowel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Associates
  • Elite Clinical Studies
  • Arkansas Gastroenterology
  • GW Research, Inc.
  • Kindred Medical Institute for Clinical Trials, LLC
  • Diagnamics Inc.
  • St. Joseph Heritage Healthcare
  • Paragon Rx Clinical
  • Grossmont Center For Clinical Research
  • Facey Medical Foundation
  • Providence Clinical Research
  • Precision Research Institute
  • Paragon Rx Clinical, Inc. - Santa Ana
  • UNISON Clinical Trials
  • Millennium Clinical Trials
  • Advanced Rx Clinical Research
  • Peak Gastroenterology Associates
  • Connecticut Clinical Research Institute
  • Chase Medical Research of Greater New Haven LLC
  • The Chappel Group Research, LLC
  • San Marcus Research Clinic Inc
  • Well Pharma Medical Research Corporation
  • New Horizon Research Center
  • Ormond Medical Arts Pharmaceutical Research Center
  • Meridien Research
  • Palm Beach Research Center
  • Research Institute of Central Florida, LLC
  • Mount Vernon Clinical Research, LLC
  • Rockford Gastroenterology Associates LTD
  • Clinical Trials Management LLC
  • Clinical Trials of America -- LA LLC
  • Meritus Center For Clinical Research
  • Meridian Clinical Research
  • Boston Clinical Trials Inc
  • Beth Israel Deaconess Medical Center
  • New England Center For Clinical Research Inc PrimaCare Research, LLC
  • MedVadis Research Corporation
  • Galen Research
  • Bozeman Health Deaconess Hospital
  • Barrett Clinic, P.C. - BTC - PPDS
  • Meridian Clinical Research
  • Clinical Research of South Nevada
  • Advanced Biomedical Research of America
  • Healthwise Medical Associates
  • Long Island Gastrointestinal Research Group LLP
  • Rochester Clinical Research, Inc
  • Carolina Digestive Health Associates
  • Carolina Digestive Health Associates
  • Peters Medical Research, LLC
  • Clinical Trials of America-NC, LLC
  • M3 Wake Research, Inc
  • PMG Research of Wilmington
  • Lyndhurst Clinical Research
  • PMG Research of Winston-Salem
  • Progressive Medicine of the Triad, LLC
  • Lillestol Research
  • Hometown Urgent Care and Research
  • Hightop Medical Research Center
  • New Horizons Clinical Research
  • Hometown Urgent Care and Research
  • Remington Davis Inc
  • Hometown Urgent Care and Research
  • Central Sooner Research
  • IPS Research Company
  • Digestive Disease Specialists, Inc.
  • Oregon Center For Clinical Investigations Inc
  • Partners In Clinical Research
  • Ocean State Clinical Research Partners
  • Mountain View Clinical Research Inc
  • WR-ClinSearch, LLC
  • New Phase Research & Development
  • MW Clinical Research Center
  • Texas Tech University Health Sciences Center
  • Southwest Clinical Trials
  • Southwest Clinical Trials
  • Quality Research Inc
  • Diagnostics Research Group
  • DCT - Stone Oak, LLC dba Discovery Clinical Trials
  • Advanced Research Institute
  • New River Valley Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

MD-7246 300 μg

MD-7246 600 μg

MD-7246 1200 μg

Placebo

Arm Description

1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets

2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets

4 MD-7246 300-μg oral tablets

4 matching placebo oral tablets

Outcomes

Primary Outcome Measures

Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period
Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week. Weekly change from baseline was calculated for each week as the weekly score minus the baseline score. Mixed model repeated measures (MMRM) results are based on a repeated measures analysis with treatment, analysis week, and treatment-by-week interaction as fixed effects and baseline as covariate. An unstructured covariance structure was used to model intra-subject correlation with subjects as a random effect. Baseline is derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization.
Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders
A 6/12 Week Abdominal Pain 30% Responder was a participant who had a decrease from baseline of ≥30% in the weekly abdominal pain score for that week for at least 6 out of the 12 weeks of the Treatment Period; for any week, a participant with < 4 daily abdominal pain scores available was considered a non-responder for that week. Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week.

Secondary Outcome Measures

Full Information

First Posted
April 22, 2019
Last Updated
February 19, 2021
Sponsor
Ironwood Pharmaceuticals, Inc.
Collaborators
Allergan Sales, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03931785
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
March 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ironwood Pharmaceuticals, Inc.
Collaborators
Allergan Sales, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Diarrhea (IBS-D)
Keywords
Abdominal pain, Diarrhea, Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
515 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MD-7246 300 μg
Arm Type
Experimental
Arm Description
1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets
Arm Title
MD-7246 600 μg
Arm Type
Experimental
Arm Description
2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets
Arm Title
MD-7246 1200 μg
Arm Type
Experimental
Arm Description
4 MD-7246 300-μg oral tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
4 matching placebo oral tablets
Intervention Type
Drug
Intervention Name(s)
MD-7246
Intervention Description
Oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching oral tablet
Primary Outcome Measure Information:
Title
Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period
Description
Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week. Weekly change from baseline was calculated for each week as the weekly score minus the baseline score. Mixed model repeated measures (MMRM) results are based on a repeated measures analysis with treatment, analysis week, and treatment-by-week interaction as fixed effects and baseline as covariate. An unstructured covariance structure was used to model intra-subject correlation with subjects as a random effect. Baseline is derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization.
Time Frame
Baseline, up to Week 12 (end of the Treatment Period)
Title
Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders
Description
A 6/12 Week Abdominal Pain 30% Responder was a participant who had a decrease from baseline of ≥30% in the weekly abdominal pain score for that week for at least 6 out of the 12 weeks of the Treatment Period; for any week, a participant with < 4 daily abdominal pain scores available was considered a non-responder for that week. Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week.
Time Frame
Baseline through Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Hormonal contraception Double-barrier method 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wilmin Bartolini, PhD
Organizational Affiliation
Ironwood Pharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Research Associates
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Elite Clinical Studies
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Arkansas Gastroenterology
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Facility Name
GW Research, Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Kindred Medical Institute for Clinical Trials, LLC
City
Corona
State/Province
California
ZIP/Postal Code
92879
Country
United States
Facility Name
Diagnamics Inc.
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Paragon Rx Clinical
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
Grossmont Center For Clinical Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Facey Medical Foundation
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Providence Clinical Research
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Precision Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Paragon Rx Clinical, Inc. - Santa Ana
City
Santa Ana
State/Province
California
ZIP/Postal Code
92703
Country
United States
Facility Name
UNISON Clinical Trials
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Millennium Clinical Trials
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Advanced Rx Clinical Research
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Connecticut Clinical Research Institute
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06010
Country
United States
Facility Name
Chase Medical Research of Greater New Haven LLC
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06517
Country
United States
Facility Name
The Chappel Group Research, LLC
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34744
Country
United States
Facility Name
San Marcus Research Clinic Inc
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Well Pharma Medical Research Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
New Horizon Research Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Ormond Medical Arts Pharmaceutical Research Center
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Meridien Research
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Research Institute of Central Florida, LLC
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Facility Name
Mount Vernon Clinical Research, LLC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Rockford Gastroenterology Associates LTD
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Clinical Trials Management LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Clinical Trials of America -- LA LLC
City
West Monroe
State/Province
Louisiana
ZIP/Postal Code
71291
Country
United States
Facility Name
Meritus Center For Clinical Research
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Meridian Clinical Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
Boston Clinical Trials Inc
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
New England Center For Clinical Research Inc PrimaCare Research, LLC
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02721
Country
United States
Facility Name
MedVadis Research Corporation
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Galen Research
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63005
Country
United States
Facility Name
Bozeman Health Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
Barrett Clinic, P.C. - BTC - PPDS
City
La Vista
State/Province
Nebraska
ZIP/Postal Code
68128
Country
United States
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Clinical Research of South Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Advanced Biomedical Research of America
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Healthwise Medical Associates
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11206
Country
United States
Facility Name
Long Island Gastrointestinal Research Group LLP
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Rochester Clinical Research, Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Carolina Digestive Health Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Carolina Digestive Health Associates
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Peters Medical Research, LLC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Clinical Trials of America-NC, LLC
City
Mount Airy
State/Province
North Carolina
ZIP/Postal Code
27030
Country
United States
Facility Name
M3 Wake Research, Inc
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
43212
Country
United States
Facility Name
PMG Research of Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Lyndhurst Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
PMG Research of Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Progressive Medicine of the Triad, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Lillestol Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Hightop Medical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
New Horizons Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
42314
Country
United States
Facility Name
Remington Davis Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Facility Name
Central Sooner Research
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
Digestive Disease Specialists, Inc.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Oregon Center For Clinical Investigations Inc
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Partners In Clinical Research
City
Cumberland
State/Province
Rhode Island
ZIP/Postal Code
02864
Country
United States
Facility Name
Ocean State Clinical Research Partners
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Mountain View Clinical Research Inc
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
WR-ClinSearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
New Phase Research & Development
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
MW Clinical Research Center
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905-2709
Country
United States
Facility Name
Southwest Clinical Trials
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Southwest Clinical Trials
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Quality Research Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DCT - Stone Oak, LLC dba Discovery Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Advanced Research Institute
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
New River Valley Research Institute
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome

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