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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ironwood Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00402337
First received: November 18, 2006
Last updated: January 29, 2013
Last verified: January 2013

November 18, 2006
January 29, 2013
November 2006
December 2007   (final data collection date for primary outcome measure)
Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency [ Time Frame: Change from Baseline to Week 4 ] [ Designated as safety issue: No ]
Change in SBM frequency during Weeks 1 through 4 of the treatment period from the weekly SBM rate obtained during the pretreatment period.
SBM Frequency
Complete list of historical versions of study NCT00402337 on ClinicalTrials.gov Archive Site
  • SBM 75% Responder for the Treatment Period (Based on the Normalized Rate) [ Time Frame: Change from Baseline to Week 4 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ 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.
  • SBM Responder
  • Daily Bowel Habits
  • Abdominal Discomfort (stool frequency, stool consistency, severity of straining, completeness of evacuation)
  • Abdominal Pain
  • Bloating
  • Constipation Severity
  • Relief of Constipation Symptoms
  • Rescue Medication
  • End of Treatment Satisfaction
  • Patient Assessment of Constipation Quality of Life
Not Provided
Not Provided
 
Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic 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
Lembo AJ, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Johnston JM. Efficacy of linaclotide for patients with chronic constipation. Gastroenterology. 2010 Mar;138(3):886-95.e1. doi: 10.1053/j.gastro.2009.12.050. Epub 2010 Jan 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
310
February 2008
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00402337
MCP-103-201
No
Ironwood Pharmaceuticals, Inc.
Ironwood Pharmaceuticals, Inc.
Not Provided
Study Director: Microbia Medical Affairs 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