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

Ironwood Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Chronic Constipation

Treatments: Drug: linaclotide acetate; Drug: Matching placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00402337

MCP-103-201

Details and patient eligibility

About

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

Enrollment: 310 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

310 participants in 5 patient groups, including a placebo group

72 ug linaclotide acetate

Active Comparator group

Treatment:

Drug: linaclotide acetate

145 ug linaclotide acetate

Active Comparator group

Treatment:

Drug: linaclotide acetate

290 ug linaclotide acetate

Active Comparator group

Treatment:

Drug: linaclotide acetate

579 ug linaclotide acetate

Active Comparator group

Treatment:

Drug: linaclotide acetate

Matching Placebo

Placebo Comparator group

Treatment:

Drug: Matching placebo