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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

NCTNCT00460811 (opens ClinicalTrials.gov in a new tab)Other idMCP-103-202
Open at ClinicalTrials.govAsk about this trial

Overview

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

United States, Canada

Start
Apr 2007
Primary completion
Feb 2008
Completion
Apr 2008
First posted
16 Apr 2007 (estimated)
Last update posted
4 Feb 2013 (estimated)
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
200720082009
  1. Ph 2

    Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

    NCT00460811

    Apr 2007 to Apr 2008

Registry summary

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

The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.

Interventions

  • Linaclotide AcetateDrug
  • Matching placeboDrug

Arms5

  • Active comparator

    72 ug linaclotide acetate

  • Active comparator

    145 ug linaclotide acetate

  • Active comparator

    290 ug linaclotide acetate

  • Active comparator

    579 ug linaclotide acetate

  • Placebo comparator

    Matching Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period

    Time frame · Change from Baseline to Week 12

    Registry description

    The change in the weekly normalized CSBM Rate during Weeks 1 through 12 of the Treatment Period from the weekly normalized CSBM Rate obtained during the Pretreatment Period. The CSBM rate was normalized based on the number of CSBMs occurring in that week, adjusting for differences in the duration of the week and black-out periods (time not covered due to a missed IVRS call) versus 7x24 hours.

Secondary outcomes(6)

  1. CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)

    Time frame · Change from Baseline to Week 12

    Registry description

    For each week of the Treatment and Posttreatment Periods, a patient was considered a CSBM Responder if for that week the patient 1) completed ≥ 4 days of IVRS questions, 2) had a CSBM rate of ≥ 3 for the week, and 3) had an increase in CSBM rate of ≥ 1 from the baseline weekly CSBM rate.

  2. Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period

    Time frame · Change from Baseline to Week 12

    Registry description

    SBMs were measured daily during the treatment period by patient calls to the IVRS.

  3. Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period

    Time frame · Change from Baseline to Week 12

    Registry description

    Stool consistency analyses were performed using the 7-point Bristol Stool Form Scale (BSFS), whereby a score of 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; and 7 = watery, no solid pieces (entirely liquid).

  4. Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period

    Time frame · Change from Baseline to Week 12

    Registry description

    Straining was assessed using a 5-point ordinal scale, whereby a score of 1 = not at all, 2 = a little bit, 3 = a moderate amount, 4 = a great deal, and 5 = an extreme amount.

  5. Change From Baseline in Degree of Relief of Irritable Bowel Syndrome (IBS) Symptoms (7-point Balanced Scale) for the Treatment Period

    Time frame · Change from Baseline to Week 12

    Registry description

    Patients provided a weekly assessment of Degree of Relief of IBS Symptoms using a 7-point balanced scale (1=completely relieved, 2=considerably relieved, 3=somewhat relieved, 4=unchanged, 5=somewhat worse, 6=considerably worse, 7=as bad as I can imagine).

  6. Change From Baseline in Abdominal Pain (5-point Ordinal Scale) for the Treatment Period

    Time frame · Change from Baseline to Week 12

    Registry description

    During the study, patients provided their self assessment of abdominal pain using a 5-point ordinal scale (1=none, 2=mild, 3=moderate, 4=severe, 5=very severe

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· Change from Baseline to Week 12

Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period

GroupValue (CSBMs per week)Spread
72 ug Linaclotide Acetate2.900.385
145 ug Linaclotide Acetate2.490.380
290 ug Linaclotide Acetate3.610.372
579 ug Linaclotide Acetate2.680.369
Matching Placebo1.010.372
Secondary and other outcome results(6)
Secondary outcomeNumber· Change from Baseline to Week 12

CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)

GroupValue (participants)
72 μg Linaclotide Acetate20
145 μg Linaclotide Acetate16
290 μg Linaclotide Acetate27
579 μg Linaclotide Acetate21
Matching Placebo10
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period

GroupValue (SBMs per week)Spread
72 ug Linaclotide Acetate4.620.457
145 ug Linaclotide Acetate4.360.453
290 ug Linaclotide Acetate4.970.442
579 ug Linaclotide Acetate5.640.439
Matching Placebo1.680.442
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period

GroupValue (units on a scale)Spread
72 μg Linaclotide Acetate1.910.133
145 μg Linaclotide Acetate1.800.131
290 μg Linaclotide Acetate2.280.127
579 μg Linaclotide Acetate2.200.127
Matching Placebo0.560.127
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period

GroupValue (units on a scale)Spread
72 μg Linaclotide Acetate-1.230.081
145 μg Linaclotide Acetate-1.200.080
290 μg Linaclotide Acetate-1.480.077
579 μg Linaclotide Acetate-1.350.078
Matching Placebo-0.710.078
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

Change From Baseline in Degree of Relief of Irritable Bowel Syndrome (IBS) Symptoms (7-point Balanced Scale) for the Treatment Period

GroupValue (units on a scale)Spread
72 μg Linaclotide Acetate-1.330.108
145 μg Linaclotide Acetate-1.370.107
290 μg Linaclotide Acetate-1.660.105
579 μg Linaclotide Acetate-1.490.104
Matching Placebo-0.810.105
Secondary outcomeLeast squares mean· Change from Baseline to Week 12

Change From Baseline in Abdominal Pain (5-point Ordinal Scale) for the Treatment Period

GroupValue (units on a scale)Spread
72 μg Linaclotide Acetate-0.710.075
145 μg Linaclotide Acetate-0.710.074
290 μg Linaclotide Acetate-0.900.073
579 μg Linaclotide Acetate-0.860.072
Matching Placebo-0.490.073

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
72 µg Linaclotide AcetateLinaclotide, 72μg dose, oral administration, once per day–0 / 7921 / 79
145 µg Linaclotide AcetateLinaclotide, 145μg dose, oral administration, once per day–0 / 8223 / 82
290 µg Linaclotide AcetateLinaclotide, 290μg dose, oral administration, once per day–1 / 8526 / 85
579 µg Linaclotide AcetateLinaclotide, 579μg dose, oral administration, once per day–0 / 8930 / 89
Matching PlaceboDose-matched placebo, oral administration, once per day–0 / 8517 / 85

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

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2023

6 results

Randomised clinical trial: effects of MD-7246 on irritable bowel syndrome with diarrhoea.

Lembo et al. 2023Alimentary pharmacology & therapeuticscited by 2

PMID 36324245DOI 10.1111/apt.17274PUB-36324245

Free to read · publisher termsCC BY-NC-ND6 results
Read at sourceSee results (6)

Indexing hint: Randomized controlled trial · 2010

7 results

Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation.

Johnston et al. 2010Gastroenterologycited by 169

PMID 20801122DOI 10.1053/j.gastro.2010.08.041PUB-20801122

Rights unknown7 results
Source linkSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Must not be pregnant or breastfeeding and agree to use birth control; * Completion of a negative colonoscopy as per American Gastroenterology Association (AGA) criteria and no clinically-significant laboratory or physical examination findings; * Meets protocol-defined criteria for IBS-C, including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria; * Demonstrates English fluency and has access to a touch-tone telephone. Exclusion Criteria: * Recent history of mushy or watery stools; * Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study; * Clinically-significant alarm symptoms; * Secondary causes of constipation or evacuation disorders; * Surgery to the gastrointestinal tract; * Usage of prohibited medications.

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