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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

NCTNCT02559206 (opens ClinicalTrials.gov in a new tab)Other idMCP-103-204
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
759 participants (actual)
Sponsor
Ironwood Pharmaceuticals, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
22 Oct 2015
Primary completion
30 Sept 2016
Completion
30 Sept 2016
First posted
24 Sept 2015 (estimated)
Last update posted
24 Apr 2020
Conditions
Irritable Bowel Syndrome With Constipation

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017
  1. Ph 2

    Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

    NCT02559206

    22 Oct 2015 to 30 Sept 2016

Registry summary

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

The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release \[IR\] formulation of linaclotide).

Interventions

  • LinaclotideDrug
  • Matching PlaceboDrug

Arms8

  • Experimental

    30 μg linaclotide DR1 and placebo

  • Experimental

    100 μg linaclotide DR1 and placebo

  • Experimental

    300 μg linaclotide DR1 and placebo

  • Experimental

    30 μg linaclotide DR2 and placebo

  • Experimental

    100 μg linaclotide DR2 and placebo

  • Experimental

    300 μg linaclotide DR2 and placebo

  • Experimental

    290 μg linaclotide IR and placebo

  • Placebo comparator

    Placebo

Primary outcomes6

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo

    Time frame · Baseline, up to Week 12

    Registry description

    Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.

  2. Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo

    Time frame · Baseline, up to Week 12

    Registry description

    Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.

  3. Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo

    Time frame · Baseline, up to Week 12

    Registry description

    A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.

  4. Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo

    Time frame · Baseline, up to Week 12

    Registry description

    A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.

  5. Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo

    Time frame · up to Week 12

    Registry description

    A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period. * Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder. * Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week. * Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week. A participant with \<4 days of completed eDiary data for that week is not considered a responder for that week.

  6. Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo

    Time frame · up to Week 12

    Registry description

    A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period. * Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder. * Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week. * Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week. A participant with \<4 days of completed eDiary data for that week is not considered a responder for that week.

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 outcomeLeast squares mean· Baseline, up to Week 12

Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo

GroupValue (score on a scale)Spread
Placebo-1.3700.241
Linaclotide IR 290 μg-1.9380.241
Linaclotide DR1 30 μg-1.6670.234
Linaclotide DR1 100 μg-1.6560.240
Linaclotide DR1 300 μg-2.1400.236
Primary outcomeLeast squares mean· Baseline, up to Week 12

Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo

GroupValue (score on a scale)Spread
Placebo-1.3700.241
Linaclotide IR 290 μg-1.9380.241
Linaclotide DR2 30 μg-1.8250.238
Linaclotide DR2 100 μg-1.6690.235
Linaclotide DR2 300 μg-1.6280.239
Primary outcomeLeast squares mean· Baseline, up to Week 12

Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo

GroupValue (CSBMs/week)Spread
Placebo1.1150.285
Linaclotide IR 290 μg2.1070.286
Linaclotide DR1 30 μg1.1630.278
Linaclotide DR1 100 μg1.4140.283
Linaclotide DR1 300 μg1.7760.279
Primary outcomeLeast squares mean· Baseline, up to Week 12

Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo

GroupValue (CSBMs/week)Spread
Placebo1.1150.285
Linaclotide IR 290 μg2.1070.286
Linaclotide DR2 30 μg1.2750.282
Linaclotide DR2 100 μg1.0190.278
Linaclotide DR2 300 μg0.8690.282
Primary outcomeCount of participants· up to Week 12

Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo

GroupValue (Participants)
Placebo14
Linaclotide IR 290 μg21
Linaclotide DR1 30 μg18
Linaclotide DR1 100 μg17
Linaclotide DR1 300 μg26
Primary outcomeCount of participants· up to Week 12

Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo

GroupValue (Participants)
Placebo14
Linaclotide IR 290 μg21
Linaclotide DR2 30 μg16
Linaclotide DR2 100 μg16
Linaclotide DR2 300 μg14

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboPlacebo: QD for 12 weeks0 / 661 / 661 / 66
Linaclotide IR 290 μgLinaclotide IR formulation: 290 μg QD for 12 weeks0 / 661 / 6610 / 66
Linaclotide DR1 30 μgLinaclotide DR1 30 μg QD for 12 weeks0 / 670 / 674 / 67
Linaclotide DR1 100 μgLinaclotide DR1 100 μg QD for 12 weeks0 / 670 / 679 / 67
Linaclotide DR1 300 μgLinaclotide DR1 300 μg QD for 12 weeks0 / 670 / 678 / 67
Linaclotide DR2 30 μgLinaclotide DR2 30 μg QD for 12 weeks0 / 670 / 670 / 67
Linaclotide DR2 100 μgLinaclotide DR2 100 μg QD for 12 weeks0 / 660 / 661 / 66
Linaclotide DR2 300 μgLinaclotide DR2 300 μg QD for 12 weeks0 / 660 / 662 / 66

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

13 results

Randomized Trial of 2 Delayed-Release Formulations of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation.

Chey et al. 2021The American journal of gastroenterologycited by 22

PMID 33065589PMC8279899DOI 10.14309/ajg.0000000000000967PUB-33065589

Free to read · publisher termsCC BY-NC-ND13 results
Read at sourceSee results (13)

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 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 diagnosis of IBS-C * Patient demonstrates continued IBS-C through Pretreatment Period * Patient maintains a minimum level of compliance with daily diary Exclusion Criteria: * Patient has history of loose or watery stools * 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

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