Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02291679
• Date of registration: 11/11/2014
• Prospective Registration: No
• Primary sponsor: Ironwood Pharmaceuticals, Inc.
• Public title: Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
• Scientific title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide (72 ug or 145 ug) Administered Orally for 12 Weeks to Patients With Chronic Idiopathic Constipation
• Date of first enrolment: October 2014
• Target sample size: 1223
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02291679
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Bernard J Lavins, MD
• Affiliation: Ironwood Pharmaceuticals, Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patient has completed a colonoscopy if one is needed according to the American
Gastroenterological Association (AGA) criteria, with no clinically significant
findings

- Patient has no clinically significant findings on a physical examination and clinical
laboratory tests

- Patient meets protocol criteria for CIC: reports < 3 bowel movements (BMs) per week
and reports one or more of the following during = 25% of BMs: straining, lumpy or hard
stools, sensation of incomplete evacuation during the 3 months before the diagnosis
with the onset at least 6 months before the diagnosis

- Patient is compliant with daily interactive voice response system (IVRS) calls

- Patient reports an average of < 3 complete spontaneous BMs (CSBMs) and = 6 SBMs per
week by the IVRS over the 14 calendar days before the Randomization Visit and the
calendar day of Randomization.

Exclusion Criteria:

- Patient has history of loose or watery stools

- Patient has symptoms of or been diagnosed with irritable bowel syndrome (IBS)

- 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

- Patient has Bristol Stool Form Scale score of 7 during Pretreatment period.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Idiopathic Constipation

Intervention(s)

Drug: Matching Placebo

Drug: Linaclotide

Primary Outcome(s)

Percentage of 12-Week CSBM Overall Responders [Time Frame: Week 12]

Secondary Outcome(s)

Change From Baseline in 12-Week Straining Score [Time Frame: Baseline, Week 1 to Week 12]

Percentage of 12-Week CSBM Overall Responders (>1 SBM/Week Subpopulation) [Time Frame: Week 12]

Percentage of Month 3 CSBM Responders [Time Frame: Month 3]

Change From Baseline in 12-Week SBM Frequency Rate [Time Frame: Baseline, Week 1 to Week 12]

Percentage of Month 2 CSBM Responders [Time Frame: Month 2]

Change From Baseline in 12-Week Abdominal Discomfort [Time Frame: Baseline, Week 1 to Week 12]

Change From Baseline in 12-Week Stool Consistency Score [Time Frame: Baseline, Week 1 to Week 12]

Change From Baseline in 12-Week Abdominal Bloating [Time Frame: Baseline, Week 1 to Week 12]

Change From Baseline in 12-Week CSBM Frequency Rate [Time Frame: Baseline, Week 1 to Week 12]

Percentage of Month 1 CSBM Responders [Time Frame: Month 1]

Secondary ID(s)

MCP-103-309

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Forest Laboratories

Results

• Results available: Yes
• Date Posted: 19/05/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02291679