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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03931785

Recruitment Status Completed

First Posted April 30, 2019

Result First Posted March 12, 2021

Last update posted March 12, 2021

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).

  • Condition or Disease:Irritable Bowel Syndrome With Diarrhea (IBS-D)
  • Intervention/Treatment: Drug: MD-7246
    Drug: Placebo
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 515 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: May 2019
  • Actual Primary Completion Date: February 2020
  • Actual Study Completion Date: March 2020
Arms and interventions
Arm Intervention/treatment
Experimental: MD-7246 1200 μg
4 MD-7246 300-μg oral tablets
Drug: MD-7246
Oral tablet
Experimental: MD-7246 300 μg
1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets
Drug: MD-7246
Oral tablet

Drug: Placebo
Matching oral tablet
Experimental: MD-7246 600 μg
2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets
Drug: MD-7246
Oral tablet

Drug: Placebo
Matching oral tablet
Placebo Comparator: Placebo
4 matching placebo oral tablets
Drug: Placebo
Matching oral tablet
Outcome Measures
  • Primary Outcome Measures: 1. Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period [ Time Frame: Baseline, up to Week 12 (end of 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.
  • 2. Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders [ Time Frame: Baseline through Week 12 ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations
Show 80 Study Locations
Sponsors and Collaborators

Ironwood Pharmaceuticals, Inc.

Allergan Sales, LLC

Investigators

Study Chair: Wilmin Bartolini, PhD Ironwood Pharmaceuticals, Inc.

More Information
  • Responsible Party: Ironwood Pharmaceuticals, Inc.
  • ClinicalTrials.gov Identifier: NCT03931785 History of Changes
  • Other Study ID Numbers: MCP-103-205
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: March 12, 2021
  • Last Verified: February 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Ironwood Pharmaceuticals, Inc.: Abdominal pain
    Diarrhea
    Irritable Bowel Syndrome
  • Additional relevant MeSH terms: Irritable Bowel Syndrome
    Syndrome
    Diarrhea
    Abdominal Pain
  • Study Type: Interventional
  • Study Design: Allocation: Randomized;Intervention Model: Parallel Assignment;Masking: Double;Primary Purpose: Treatment
  • Condition: Irritable Bowel Syndrome With Diarrhea (IBS-D)
  • Interventions : Drug: MD-7246
    Drug: Placebo
  • Enrollment: 515
Participant flow
Recruitment Details
Pre-assignment Details This study included a Pretreatment Period, 14 to 21 days immediately before randomization. During this period, participants underwent symptomatic assessments in an electronic diary (eDiary); those who satisfied all entry criteria based on these assessments entered the Treatment Period and were randomized to 1 of 4 treatments: MD-7246 300, 600, or 1200 μg or placebo (1:1:1:1). Of the 515 participants in the Pretreatment Period, 127 were not randomized.
Arm/Group title MD-7246 1200 μg MD-7246 600 μg MD-7246 300 μg Placebo
Arm/Group Description 4 MD-7246 300-μg oral tablets QD for 12 weeks 2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets QD for 12 weeks 1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets QD for 12 weeks 4 matching placebo oral tablets once daily (QD) for 12 weeks
Period Title: Overall Study
Started 97 97 97 97
Completed 86 84 90 92
Not Completed 11 13 7 5
Reason Not Completed
Pregnancy 1
Withdrawal by Subject 1 4 2
Other Not specified 2 2 2
Noncompliance With Study drug 1
Protocol Violation 1
Adverse Event 4 3 1
Lost to Follow-up 3 4 1 4
Baseline Characteristics
Arm/Group title TotalMD-7246 1200 μgMD-7246 600 μgMD-7246 300 μgPlacebo
Arm/Group Description Total of all reporting groups4 MD-7246 300-μg oral tablets QD for 12 weeks2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets QD for 12 weeks1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets QD for 12 weeks4 matching placebo oral tablets once daily (QD) for 12 weeks
Overall Number of Baseline Participants 38897979797
Baseline Analysis Population Description Safety Population: all participants who received at least one dose of study drug
Outcome Measures
1. PrimaryOutcome
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
Outcome Measure Data
Analysis Population Description
Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at Baseline and during the treatment period.
 
Arm/Group title MD-7246 1200 μgMD-7246 600 μgMD-7246 300 μgPlacebo
Arm/Group Description 4 MD-7246 300-μg oral tablets QD for 12 weeks2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets QD for 12 weeks1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets QD for 12 weeks4 matching placebo oral tablets once daily (QD) for 12 weeks
Overall Number of Participants Analyzed 97979797
Measure Type: Number
Unit of Measure: percentage of participants
48.5
44.3
56.7
55.7
Statistical Analysis Overview Comparison Group Selection Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders
Comments
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3157
Comments
Method Cochran-Mantel-Haenszel
Comments
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.749
Confidence Interval (2-Sided ) 95.0%
0.425 to 1.317
Estimation Comments Odds ratio for response (MD-7246 : placebo)
2. PrimaryOutcome
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)
Outcome Measure Data
Analysis Population Description
Modified Intent-to-Treat (mITT) Population: all randomized participants who received at least 1 dose of study drug. Participants with an assessment at Baseline and during the treatment period.
 
Arm/Group title MD-7246 1200 μgMD-7246 600 μgMD-7246 300 μgPlacebo
Arm/Group Description 4 MD-7246 300-μg oral tablets QD for 12 weeks2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets QD for 12 weeks1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets QD for 12 weeks4 matching placebo oral tablets once daily (QD) for 12 weeks
Overall Number of Participants Analyzed 97979797
Measure Type: Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.95
-1.58
-1.93
-2.01
Statistical Analysis Overview Comparison Group Selection Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders, Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period
Comments
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8098
Comments
Method MMRM
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.06
Confidence Interval (2-Sided ) 95.0%
-0.44 to 0.56
Estimation Comments MD-7246 minus placebo
Adverse Events
Time Frame From the first dose of double-blind study drug and within 1 day of the date of last dose of double-blind study drug in the treatment period (up to Week 12 / Day 85). Mean treatment duration was 82.8, 77.3, and 80.8 days in the MD-7246 300, 600, and 1200 μg groups, respectively, and 83.3 days in the placebo group.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MD-7246 1200 μgMD-7246 600 μgMD-7246 300 μgPlacebo
Arm/Group Description 4 MD-7246 300-μg oral tablets QD for 12 weeks2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets QD for 12 weeks1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets QD for 12 weeks4 matching placebo oral tablets once daily (QD) for 12 weeks
Serious Adverse Events
  Placebo MD-7246 300 μg MD-7246 600 μg MD-7246 1200 μg
Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%)
Total 0/97 (0.00%) 0/97 (0.00%) 0/97 (0.00%) 1/97 (1.03%)
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy 0 /97 (0.00%) 0 /97 (0.00%) 0 /97 (0.00%) 1 /97 (1.03%)
Show Other (Not Including Serious) Adverse Events
  Placebo MD-7246 300 μg MD-7246 600 μg MD-7246 1200 μg
Affected at Risk (%) Affected at Risk (%) Affected at Risk (%) Affected at Risk (%)
Total 1/97 (1.03%) 3/97 (3.09%) 3/97 (3.09%) 4/97 (4.12%)
Gastrointestinal disorders
Vomiting 0 /97 (0.00%) 0 /97 (0.00%) 0 /97 (0.00%) 2 /97 (2.06%)
Abdominal distension 0 /97 (0.00%) 0 /97 (0.00%) 2 /97 (2.06%) 0 /97 (0.00%)
Abdominal pain 2 /97 (2.06%) 2 /97 (2.06%) 0 /97 (0.00%) 1 /97 (1.03%)
Diarrhoea 0 /97 (0.00%) 1 /97 (1.03%) 2 /97 (2.06%) 2 /97 (2.06%)
Abdominal pain upper 0 /97 (0.00%) 0 /97 (0.00%) 4 /97 (4.12%) 1 /97 (1.03%)
Constipation 2 /97 (2.06%) 1 /97 (1.03%) 3 /97 (3.09%) 2 /97 (2.06%)
Nausea 1 /97 (1.03%) 3 /97 (3.09%) 3 /97 (3.09%) 4 /97 (4.12%)
General disorders
Fatigue 0 /97 (0.00%) 0 /97 (0.00%) 2 /97 (2.06%) 1 /97 (1.03%)
Infections and infestations
Bacterial vaginosis 0 /97 (0.00%) 0 /97 (0.00%) 0 /97 (0.00%) 2 /97 (2.06%)
Bronchitis 0 /97 (0.00%) 0 /97 (0.00%) 1 /97 (1.03%) 2 /97 (2.06%)
Vulvovaginal mycotic infection 1 /97 (1.03%) 0 /97 (0.00%) 2 /97 (2.06%) 2 /97 (2.06%)
Urinary tract infection 3 /97 (3.09%) 1 /97 (1.03%) 2 /97 (2.06%) 1 /97 (1.03%)
Sinusitis 1 /97 (1.03%) 1 /97 (1.03%) 0 /97 (0.00%) 4 /97 (4.12%)
Influenza 1 /97 (1.03%) 1 /97 (1.03%) 1 /97 (1.03%) 5 /97 (5.15%)
Upper respiratory tract infection 7 /97 (7.22%) 1 /97 (1.03%) 3 /97 (3.09%) 5 /97 (5.15%)
Nasopharyngitis 4 /97 (4.12%) 5 /97 (5.15%) 5 /97 (5.15%) 3 /97 (3.09%)
Injury, poisoning and procedural complications
Procedural pain 0 /97 (0.00%) 0 /97 (0.00%) 2 /97 (2.06%) 1 /97 (1.03%)
Metabolism and nutrition disorders
Dehydration 0 /97 (0.00%) 0 /97 (0.00%) 0 /97 (0.00%) 2 /97 (2.06%)
Hyperglycaemia 0 /97 (0.00%) 2 /97 (2.06%) 1 /97 (1.03%) 0 /97 (0.00%)
Diabetes mellitus inadequate control 1 /97 (1.03%) 2 /97 (2.06%) 0 /97 (0.00%) 1 /97 (1.03%)
Nervous system disorders
Dizziness 0 /97 (0.00%) 0 /97 (0.00%) 1 /97 (1.03%) 3 /97 (3.09%)
Headache 2 /97 (2.06%) 4 /97 (4.12%) 4 /97 (4.12%) 4 /97 (4.12%)
Psychiatric disorders
Insomnia 0 /97 (0.00%) 0 /97 (0.00%) 2 /97 (2.06%) 1 /97 (1.03%)
Respiratory, thoracic and mediastinal disorders
Sinus congestion 0 /97 (0.00%) 0 /97 (0.00%) 0 /97 (0.00%) 2 /97 (2.06%)
Oropharyngeal pain 1 /97 (1.03%) 2 /97 (2.06%) 1 /97 (1.03%) 1 /97 (1.03%)
Vascular disorders
Hypertension 1 /97 (1.03%) 2 /97 (2.06%) 1 /97 (1.03%) 0 /97 (0.00%)
Limitations and Caveats

[Not Specified]

More Information
Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

PI may publish or disclose the results of the study 24 months after final data lock provided that sponsor can review the publication prior to public release, sponsor can request removal of confidential information of sponsor (not including results of trial), and sponsor can request a publication delay in order to protect potentially patentable information. Furthermore, if a publication committee is developing an initial publication, PI is to delay disclosure until that publication is published.

Results Point of Contact
  • ClinicalTrials.gov Identifier: NCT03931785 History of Changes
  • Other Study ID Numbers: MCP-103-205
  • First Submitted: April 22, 2019
  • First Posted: April 30, 2019
  • Results First Submitted: February 19, 2021
  • Results First Posted: March 12, 2021
  • Last Update Posted: March 12, 2021