A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)

NCT02837783 | Terminated Phase 4 Results

• 1 other identifier: MCP-103-403
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this trial is to determine the effect of linaclotide on abdominal girth in IBS-C participants with the baseline symptoms of abdominal bloating and an increased abdominal girth.

Conditions

Irritable Bowel Syndrome Characterized by Constipation

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Abdominal Girth at Week 4

  Mean change in abdominal girth (physical measure of bloating/distension) as measured by area under the curve (AUC), determined by 24-hour abdominal inductance plesthymography (AIP; with hourly averages). The AUC was calculated using the Trapezoidal method from the first reliable hour of measurement to last measurement (bedtime). The AUC for each participant was then individually standardized by dividing the total AUC over the period by that patient's number of hours of measurement included in the AUC. (Therefore, the time element was removed from the standardized AUC, and the unit of measure for this outcome is centimeters \[cm\]).

  Baseline, Week 4

Secondary Outcomes (9)

• Change From Baseline in Abdominal Girth at Week 2

  Baseline, Week 2

• Percent Change From Baseline in Maximal Abdominal Girth at Week 4

  Baseline, Week 4

• Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 1

  Baseline, Week 1

• Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 2

  Baseline, Week 2

• Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 3

  Baseline, Week 3

Study Arms (2)

290 μg linaclotide

EXPERIMENTAL

Linaclotide Oral, once daily

Drug: Linaclotide

Matching Placebo

PLACEBO COMPARATOR

Matching Placebo Oral, once daily

Drug: Placebo

Interventions

Linaclotide DRUG

Oral, once daily

290 μg linaclotide

Placebo DRUG

Oral, one daily

Matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient meets protocol criteria for diagnosis of IBS-C, abdominal pain, abdominal bloating and abdominal girth

You may not qualify if:

• Patient has history of loose or watery stools
• Patient has both clinically significant findings and unexplained clinically significant alarm symptoms
• Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
• Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments

Sponsors & Collaborators

• Ironwood Pharmaceuticals, Inc.: lead
• Manchester University NHS Foundation Trust: collaborator

Study Sites (1)

Peter Whorwell

Wythenshawe, Manchester, United Kingdom

Location

MeSH Terms

Interventions

linaclotide

Limitations and Caveats

Due to an insufficient sample size, no conclusions could be drawn regarding efficacy.

Results Point of Contact

• Title: Lara Lane
• Organization: Ironwood Pharmaceuticals, Inc.

llane@ironwoodpharma.com

(617) 621-7722

Study Officials

• Peter Whorwell

  University Hospital of South Manchester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: July 20, 2016
• Study Start: December 21, 2016
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: December 6, 2021
• Results First Posted: December 6, 2021

Record last verified: 2021-11

Locations

GB (1)