A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Short name D5630C00001

NCTNCT01880424Other idICP-103-307

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Overview

Status: Completed
Phase: Phase 3
Enrollment: 1,722 participants (actual)
Sponsor: AstraZeneca · Industry
Design: Randomized · Double masking
Countries: 5 countries
United States, Australia, Canada, China, New Zealand
Start: Jul 2013
Primary completion: May 2015
Completion: May 2015
First posted: 19 Jun 2013 (estimated)
Last update posted: 27 Sept 2016 (estimated)
Conditions: Irritable Bowel Syndrome With Constipation (IBS-C)

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2013201420152016

Ph 3
D5630C00001
NCT01880424
Jul 2013 to May 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This clinical trial is an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo. Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be randomized at up to 60 trial centers in China, Australia, and New Zealand. The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12 weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment Period, patients meeting the entry criteria for this trial will be randomized to one of two double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).

Interventions

PlaceboDrug
LinaclotideDrug

Arms2

Placebo comparator
controlled arm
Experimental
treatment arm

Primary outcomes2

Outcomes the sponsor listed as primary.

12-week Abdominal Pain/Abdominal Discomfort Weekly Responder
Time frame · Baseline and Weeks 1-12 during the Treatment Period
Registry description
A 12-week Abdominal Pain/Abdominal Discomfort Responder is a patient who meets the Abdominal Pain/Abdominal Discomfort Weekly Responder criteria (i.e., an improvement of ≥30% from baseline in either the mean abdominal pain score or mean abdominal discomfort score for that week, with neither score worsening from baseline for that week) for at least 6 out of the 12 weeks of the Treatment Period. Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point numerical rating scale (NRS) where 0 represents no abdominal pain and 10 represents very severe abdominal pain. Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.
12-week Irritable Bowel Syndrome (IBS) Degree of Relief Responder
Time frame · Baseline and Weeks 1-12 during the Treatment Period
Registry description
A 12-week IBS Degree of Relief Responder is a patient who meets the IBS Degree of Relief Weekly Responder criteria (i.e., response to the degree of relief of IBS symptoms question for that week was "Considerably relieved" or "Completely relieved") for at least 6 out of the 12 weeks of the Treatment Period. Degree of relief of IBS symptoms (in the last 7 days) was assessed weekly by patients on a 7-point balanced ordinal scale where 1 = Completely relieved, 4 = Unchanged, and 7 = As bad as I can imagine.

Secondary outcomes(7)

Change From Baseline in 12-week Complete Spontaneous Bowel Movement Frequency Rate
Time frame · Baseline and 12-week Treatment Period
Registry description
The change from baseline in 12-week CSBM frequency (i.e., average weekly CSBM frequency over the 12 weeks of the Treatment Period). A spontaneous bowel movement (SBM) is defined as a bowel movement without laxative use in the preceding 24 hours. A CSBM is defined as an SBM that is associated with a sense of complete evacuation.
Change From Baseline in 12-week Spontaneous Bowel Movement Frequency Rate
Time frame · Baseline and 12-week Treatment Period
Registry description
The change from baseline in 12-week SBM frequency (i.e., average weekly SBM frequency over the 12 weeks of the Treatment Period). SBM is defined as a bowel movement without laxative use in the preceding 24 hours.
Change From Baseline in 12-week Stool Consistency
Time frame · Baseline and 12-week Treatment Period
Registry description
The change from baseline in 12-week stool consistency (i.e., the average of the non-missing Bristol Stool Form Scale \[BSFS\] score from the SBMs occurring during the 12-week Treatment Period). Consistency of each bowel movement was assessed daily by patients using the 7-point BSFS (1=Separate hard lumps like nuts \[difficult to pass\] to 7=Watery, no solid pieces \[entirely liquid\]).
Change From Baseline in 12-week Severity of Straining
Time frame · Baseline and 12-week Treatment Period
Registry description
The change from baseline in 12-week severity of straining (i.e., the average of the non-missing straining scores from the SBMs occurring during the 12-week Treatment Period). Severity of straining was assessed daily by patients on a 5-point ordinal scale (1=Not at all to 5=An extreme amount).
Change From Baseline in 12-week Abdominal Bloating
Time frame · Baseline and 12-week Treatment Period
Registry description
The change from baseline in 12-week abdominal bloating (i.e., the average of the non-missing daily abdominal bloating scores reported during the 12-week Treatment Period). Abdominal bloating (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal bloating and 10 represents very severe abdominal bloating.
Change From Baseline in 12-week Abdominal Pain
Time frame · Baseline and 12-week Treatment Period
Registry description
The change from baseline in 12-week abdominal pain (i.e., the average of the non-missing daily abdominal pain scores reported during the 12-week Treatment Period). Abdominal pain at its worst (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Change From Baseline in 12-week Abdominal Discomfort
Time frame · Baseline and 12-week Treatment Period
Registry description
The change from baseline in 12-week abdominal discomfort (i.e., the average of the non-missing daily abdominal discomfort scores reported during the 12-week Treatment Period). Abdominal discomfort (in the last 24 hours) was assessed daily by patients on an 11-point NRS where 0 represents no abdominal discomfort and 10 represents very severe abdominal discomfort.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Baseline and Weeks 1-12 during the Treatment Period

12-week Abdominal Pain/Abdominal Discomfort Weekly Responder

Group	Value (Participants)
Linaclotide Arm	250
Placebo Arm	206

Primary outcomeNumber· Baseline and Weeks 1-12 during the Treatment Period