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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00460811
Recruitment Status : Completed
First Posted : April 16, 2007
Results First Posted : January 30, 2013
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome With Constipation Drug: Linaclotide Acetate Drug: Matching placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 72 ug linaclotide acetate Drug: Linaclotide Acetate
Oral, once daily
Active Comparator: 145 ug linaclotide acetate Drug: Linaclotide Acetate
Oral, once daily
Active Comparator: 290 ug linaclotide acetate Drug: Linaclotide Acetate
Oral, once daily
Active Comparator: 579 ug linaclotide acetate Drug: Linaclotide Acetate
Oral, once daily
Placebo Comparator: Matching Placebo Drug: Matching placebo
Oral, once daily


Outcome Measures
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Primary Outcome Measures :
  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 ]

    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 Outcome Measures :
  1. CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate) [ Time Frame: Change from Baseline to Week 12 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00460811


Locations
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Sponsors and Collaborators
Ironwood Pharmaceuticals, Inc.
Investigators
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Study Director: Microbia Medical Director, MD Microbia, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00460811    
Other Study ID Numbers: MCP-103-202
First Posted: April 16, 2007    Key Record Dates
Results First Posted: January 30, 2013
Last Update Posted: February 4, 2013
Last Verified: January 2013
Keywords provided by Ironwood Pharmaceuticals, Inc.:
Irritable Bowel Syndrome with Constipation
IBS
Irritable Bowel Syndrome
 linaclotide acetate
linaclotide
MD-1100
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Constipation
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Linaclotide
Guanylyl Cyclase C Agonists
Enzyme Activators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents