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Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

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ClinicalTrials.gov Identifier: NCT00765882
Recruitment Status : Completed
First Posted : October 3, 2008
Results First Posted : January 30, 2013
Last Update Posted : January 30, 2013
Sponsor:
Collaborator:
Ironwood Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Forest Laboratories

Brief Summary:
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder

Condition or disease Intervention/treatment Phase
Chronic Constipation Drug: Linaclotide 290 micrograms Drug: Linaclotide 145 micrograms Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 633 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks in Patients With Chronic Constipation
Study Start Date : September 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: 1
Linaclotide 290 micrograms
Drug: Linaclotide 290 micrograms
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Experimental: 2
Linaclotide 145 micrograms
Drug: Linaclotide 145 micrograms
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Placebo Comparator: 3
Matching placebo
Drug: Placebo
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study




Primary Outcome Measures :
  1. Complete Spontaneous Bowel Movement (CSBM) Overall Responder [ Time Frame: Change from Baseline to Week 12 ]

    A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline.

    A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.

    An SBM was 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 Outcome Measures :
  1. 12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate [ Time Frame: Change from Baseline to Week 12 ]
    The number of CSBMs per week.

  2. 12-Week Spontaneous Bowel Movement (SBM) Frequency Rate [ Time Frame: Change from Baseline to Week 12 ]
    A patient's 12-week spontaneous bowel movement (SBM) frequency rate was the number of SBMs per week calculated over the 12-weeks of the treatment period.

  3. 12-Week Stool Consistency [ Time Frame: Change from Baseline to Week 12 ]

    The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:

    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]

  4. 12-Week Severity of Straining [ Time Frame: Change from Baseline to Week 12 ]
    Straining is measured on a 5-point scale, where a value of 1 is "not at all" and a value of 5 is "an extreme amount.

  5. 12-Week Abdominal Discomfort [ Time Frame: Change from Baseline to Week 12 ]
    Abdominal discomfort is based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe."

  6. 12-Week Bloating [ Time Frame: Change from Baseline to Week 12 ]
    Bloating was based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe".

  7. 12-Week Constipation Severity [ Time Frame: Change from Baseline to Week 12 ]
    Constipation severity was based on a 5-point ordinal scale where a value of l is "none" and a value of 5 is "very severe".



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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:

  • Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
  • Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
  • Patient meets protocol criteria for CC: reports < 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs
  • Patient demonstrates continued chronic constipation through Pretreatment Period
  • Patient is compliant with IVRS

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

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): NCT00765882


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Sponsors and Collaborators
Forest Laboratories
Ironwood Pharmaceuticals, Inc.
Investigators
Study Director: Paul F.C. Eng, PhD Forest Laboratories