Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

Overview

The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.

Full Title of Study: “A Randomized, Multicenter, Double-blind, Placebo-controlled, Dose-range-finding, Parallel-group, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2007

Interventions

  • Drug: linaclotide acetate
    • oral, once daily.
  • Drug: Matching placebo
    • oral, once daily

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency
    • Time Frame: Change from Baseline to Week 4
    • Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.

Secondary Measures

  • SBM 75% Responder for the Treatment Period (Based on the Normalized Rate)
    • Time Frame: Change from Baseline to Week 4
    • A patient was an SBM 75% Responder if the patient was an SBM Responder for ≥3 of the 4 treatment period weeks. For each week of the treatment and postreatment periods, a patient was considered an SBM Responder if for that week the patient 1) completed ≥4 days of IVRS questions,2) had an SBM rate of ≥ 3 for the week, and 3) had an increase in SBM rate of ≥ 1 from their baseline weekly SBM rate.
  • CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate)
    • Time Frame: Change from Baseline to Week 4
    • A patient was a complete spontaneous bowel movement (CSBM) 75% Responder if the patient was a CSBM Responder for ≥3 of the 4 treatment period weeks. For each week of the treatment and postreatment 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 their baseline weekly CSBM rate.
  • Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period
    • Time Frame: Change from Baseline to Week 4
    • CSBMs measured daily during the treatment period. During each daily phone call into the IVRS, patients were asked: How many bowel movements did you have today or yesterday after your last call?
  • Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period
    • Time Frame: Change from Baseline to Week 4
    • Stool consistency analyses were performed using the 7-point BSFS, whereby a score of 1 = 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 = entirely liquid.
  • Change From Baseline in Straining Score for the Treatment Period
    • Time Frame: Change from Baseline to Week 4
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Patient is 18 years of age or older – Patient meets colonoscopy requirements according to the American Gastroenterological Association – Patient meets criteria for chronic constipation including weekly bowel movement frequency requirements and reports one or more symptoms of constipation according to protocol requirements – Patient has successfully completed study requirements with no clinically-significant findings: physical exam, ECG, clinical laboratory tests – Patient is fluent in English Exclusion Criteria:

  • Patient reports loose or watery stools – Patient meets criteria for IBS including protocol-defined abdominal discomfort or pain – Patient may not take prohibited medications per protocol – Medical diagnoses, medical conditions, or family history that would not make the patient a good candidate for the study or limit the patient's ability to complete the clinical study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ironwood Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Microbia Medical Affairs, Study Director, Microbia, Inc.

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