Skip to main content
OpenTrials
Completed

NCT Number: NCT00402337

Dose-range-finding, 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Constipation Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Microbia Investigational Site, Huntsville, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

linaclotide acetate

Drug

oral, once daily.

Matching Placebo

Drug

oral, once daily

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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?

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Ironwood Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Nov 22, 2006
Registry last updated
Mar 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.