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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

NCTNCT02291679 (opens ClinicalTrials.gov in a new tab)Other idMCP-103-309
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,223 participants (actual)
Sponsor
Ironwood Pharmaceuticals, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Oct 2014
Primary completion
Aug 2015
Completion
Aug 2015
First posted
14 Nov 2014 (estimated)
Last update posted
15 Jun 2017
Conditions
Chronic Idiopathic Constipation

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 3

    Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

    NCT02291679

    Oct 2014 to Aug 2015

Registry summary

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

The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.

Interventions

  • LinaclotideDrug
  • Matching PlaceboDrug

Arms3

  • Experimental

    72 μg linaclotide

    72 μg oral linaclotide, once daily for 12 weeks

  • Experimental

    145 μg linaclotide

    145 μg oral linaclotide, once daily for 12 weeks

  • Placebo comparator

    Placebo

    matching placebo, once daily for 12 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of 12-Week CSBM Overall Responders

    Time frame · Week 12

    Registry description

    A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥ 4 IVRS calls for the specified week. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a bowel movement BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.

Secondary outcomes(10)

  1. Change From Baseline in 12-Week CSBM Frequency Rate

    Time frame · Baseline, Week 1 to Week 12

    Registry description

    A participant's 12-week CSBM Frequency Rate is the CSBM rate (CSBMs/week) calculated over the 12 weeks of the Treatment Period. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.

  2. Change From Baseline in 12-Week SBM Frequency Rate

    Time frame · Baseline, Week 1 to Week 12

    Registry description

    A participant's 12-week SBM Frequency Rate is the SBM rate (SBMs/week) calculated over the 12-weeks of the Treatment Period. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.

  3. Change From Baseline in 12-Week Stool Consistency Score

    Time frame · Baseline, Week 1 to Week 12

    Registry description

    Stool consistency was measured daily using the 7-point ordinal Bristol Stool Form Scale (BSFS; 1 = separate hard lumps like nuts \[difficult to pass\]; 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges \[passed easily\]; 6 = fluffy pieces with ragged edges, a mushy stool; 7 = watery, no solid pieces \[entirely liquid\]). The participant's BSFS score for the Treatment Period is the average of the non-missing BSFS scores from the SBMs reported by the participant during the 12-week Treatment Period.

  4. Change From Baseline in 12-Week Straining Score

    Time frame · Baseline, Week 1 to Week 12

    Registry description

    Straining was measured daily using a 5-point ordinal scale (1 = not at all; 2 = a little bit; 3 = a moderate amount; 4 = a great deal; 5 = an extreme amount). The participant's straining score for the Treatment Period is the average of the non-missing straining scores from the SBMs reported by the participant during the 12-week Treatment Period.

  5. Percentage of 12-Week CSBM Overall Responders (>1 SBM/Week Subpopulation)

    Time frame · Week 12

    Registry description

    A 12-week CSBM Overall Responder is a participant who was a CSBM Weekly Responder for at least 9 of the 12 weeks of the Treatment Period. A CSBM Weekly Responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline, and completed ≥4 IVRS calls for the specified week. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.

  6. Percentage of Month 1 CSBM Responders

    Time frame · Month 1

    Registry description

    A Month 1 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 1 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.

  7. Percentage of Month 2 CSBM Responders

    Time frame · Month 2

    Registry description

    A Month 2 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 2 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.

  8. Percentage of Month 3 CSBM Responders

    Time frame · Month 3

    Registry description

    A Month 3 CSBM Responder is a participant who is a CSBM weekly responder for at least 3 of the 4 weeks of Month 3 of the Treatment Period. A CSBM weekly responder is a participant who had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline based on a minimum of 4 complete IVRS calls for that week. A CSBM is defined as an SBM that is associated with a sense of complete evacuation. An SBM is defined as a BM that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.

  9. Change From Baseline in 12-Week Abdominal Bloating

    Time frame · Baseline, Week 1 to Week 12

    Registry description

    Abdominal bloating was measured daily using an 11-point NRS (0 = none; 10 = very severe). The participant's abdominal bloating score for the Treatment Period is the average of the non-missing daily participant assessments of abdominal bloating scores reported during the 12-week Treatment Period.

  10. Change From Baseline in 12-Week Abdominal Discomfort

    Time frame · Baseline, Week 1 to Week 12

    Registry description

    Abdominal discomfort was measured daily using an 11-point NRS (0 = none; 10 = very severe). The participant's abdominal discomfort score for the Treatment Period is the average of the non-missing daily participant assessments of abdominal discomfort scores reported during the 12-week Treatment Period.

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· Week 12

Percentage of 12-Week CSBM Overall Responders

GroupValue (percentage of participants)
Placebo4.7
72 μg Linaclotide13.4
Secondary and other outcome results(7)
Secondary outcomeLeast squares mean· Baseline, Week 1 to Week 12

Change From Baseline in 12-Week CSBM Frequency Rate

GroupValue (CSBMs/week)Spread
Placebo0.8840.142
72 μg Linaclotide1.7250.139
Secondary outcomeLeast squares mean· Baseline, Week 1 to Week 12

Change From Baseline in 12-Week SBM Frequency Rate

GroupValue (SBMs/week)Spread
Placebo1.3290.169
72 μg Linaclotide2.3660.166
Secondary outcomeLeast squares mean· Baseline, Week 1 to Week 12

Change From Baseline in 12-Week Stool Consistency Score

GroupValue (units on a scale)Spread
Placebo1.0650.076
72 μg Linaclotide1.6930.074
Secondary outcomeLeast squares mean· Baseline, Week 1 to Week 12

Change From Baseline in 12-Week Straining Score

GroupValue (units on a scale)Spread
Placebo-0.7890.051
72 μg Linaclotide-1.1180.050
Secondary outcomeNumber· Week 12

Percentage of 12-Week CSBM Overall Responders (>1 SBM/Week Subpopulation)

GroupValue (percentage of participants)
Placebo7.1
72 μg Linaclotide17.2
Secondary outcomeNumber· Month 1

Percentage of Month 1 CSBM Responders

GroupValue (percentage of participants)
Placebo6.2
72 μg Linaclotide14.8
Secondary outcomeNumber· Month 2

Percentage of Month 2 CSBM Responders

GroupValue (percentage of participants)
Placebo9.5
72 μg Linaclotide18.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboMatching placebo, once daily for 12 weeks–4 / 40128 / 401
72 μg Linaclotide72 μg oral linaclotide, once daily for 12 weeks–3 / 41179 / 411
145 μg Linaclotide145 μg oral linaclotide, once daily for 12 weeks–2 / 41191 / 411

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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