Phase 2
N=310
Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation
Chronic Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00402337 ↗Enrolled (actual)
310
Serious AEs
0.7%
Results posted
Mar 2013
Primary outcome: Primary: Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency — 2.59; 3.25; 3.57; 4.29 SBMs per week — p=0.0337
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- linaclotide acetate (Drug); Matching placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ironwood Pharmaceuticals, Inc.
- Primary completion
- Dec 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Pretreatment in Weekly Normalized Spontaneous Bowel Movement (SBM) Frequency |
2.59; 3.25; 3.57; 4.29; 1.45 | 0.0337 sig |
| SECONDARY SBM 75% Responder for the Treatment Period (Based on the Normalized Rate) |
35; 31; 38; 42; 22 | — |
| SECONDARY CSBM 75% Responder for the Treatment Period (Based on the Normalized Rate) |
11; 15; 20; 18; 5 | — |
| SECONDARY Change From Baseline in the Weekly Normalized CSBM Rate for the Treatment Period |
1.47; 1.59; 1.75; 2.26; 0.45 | — |
| SECONDARY Change From Baseline in Stool Consistency (BSFS) Score for the Treatment Period |
1.35; 1.57; 1.68; 2.00; 0.50 | — |
| SECONDARY Change From Baseline in Straining Score for the Treatment Period |
-0.71; -0.97; -1.11; -1.14; -0.52 | — |
Summary
The primary purpose of this study is to evaluate the efficacy and safety of administration of linaclotide acetate in patients with chronic constipation.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00402337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.