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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00460811
First received: April 13, 2007
Last updated: January 29, 2013
Last verified: January 2013

April 13, 2007
January 29, 2013
April 2007
February 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]

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.

Not Provided
Complete list of historical versions of study NCT00460811 on ClinicalTrials.gov Archive Site
  • CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate) [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in the Weekly Normalized SBM Rate for the Treatment Period [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: No ]
    SBMs were measured daily during the treatment period by patient calls to the IVRS.
  • Change From Baseline in Stool Consistency (7-point Ordinal BSFS) for the Treatment Period [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: No ]
    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).
  • Change From Baseline in Straining (5-point Ordinal Scale) for the Treatment Period [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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).
  • Change From Baseline in Abdominal Pain (5-point Ordinal Scale) for the Treatment Period [ Time Frame: Change from Baseline to Week 12 ] [ Designated as safety issue: No ]
    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
Not Provided
Not Provided
Not Provided
 
Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-design, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Irritable Bowel Syndrome With Constipation

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Irritable Bowel Syndrome With Constipation
  • Drug: Linaclotide Acetate
    Oral, once daily
  • Drug: Matching placebo
    Oral, once daily
  • Active Comparator: 72 ug linaclotide acetate
    Intervention: Drug: Linaclotide Acetate
  • Active Comparator: 145 ug linaclotide acetate
    Intervention: Drug: Linaclotide Acetate
  • Active Comparator: 290 ug linaclotide acetate
    Intervention: Drug: Linaclotide Acetate
  • Active Comparator: 579 ug linaclotide acetate
    Intervention: Drug: Linaclotide Acetate
  • Placebo Comparator: Matching Placebo
    Intervention: Drug: Matching placebo
Johnston JM, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, O'Dea C, Baird M, Lembo AJ. Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation. Gastroenterology. 2010 Dec;139(6):1877-1886.e2. Epub 2010 Aug 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
420
April 2008
February 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00460811
MCP-103-202
Not Provided
Ironwood Pharmaceuticals, Inc.
Ironwood Pharmaceuticals, Inc.
Not Provided
Study Director: Microbia Medical Director, MD Microbia, Inc.
Ironwood Pharmaceuticals, Inc.
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP