Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation

NCT ID: NCT01696643

Last Updated: 2018-11-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1407 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-12
• Study Completion Date: 2014-07-21

Brief Summary

The purpose of this study is to evaluate the long-term safety and tolerability of CB-5945 for the treatment of opioid-induced constipation (OIC) in adults taking opioid therapy for chronic non-cancer pain.

Detailed Description

This is a multicenter, double-blind, placebo-controlled, parallel-group study in participants with OIC taking opioid therapy for chronic non-cancer pain. Approximately 1,400 participants (approximately 700 participants per treatment group) with OIC will be randomized at approximately 225 study centers to receive either 0.25 milligrams (mg) CB-5945 twice daily (BID) or a matching placebo BID for the 52-week double-blind treatment period, followed by a 4-week follow-up period. All randomized participants will be evaluated for safety, tolerability, and quality of life from the first dose of study drug through Week 56.

Conditions

Opioid-Induced Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CB-5945

0.25 milligrams (mg) CB-5945, administered orally, twice daily (BID) for 52 weeks

Group Type: EXPERIMENTAL

CB-5945

Intervention Type: DRUG

Placebo

Placebo, administered orally, BID for 52 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

CB-5945

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Bevenopran

Eligibility Criteria

Inclusion Criteria

• Is taking a stable daily dose of opioids of ≥30-mg morphine-equivalent total daily dose (METDD) for chronic non-cancer pain
• Has constipation that is caused by the chronic use of opioids
• Is willing to use only the study-provided laxative(s) and to discontinue use of all other laxatives, enemas, stool softeners, and other medications to treat constipation (for example, lubiprostone) during the study period (from Screening until the last study assessment).
• Is able and willing to refrain from facilitating defecation via manual maneuvers (for example, digital evacuation or support of the pelvic floor) during the study period (from Screening to the last study assessment)

Exclusion Criteria

• Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for example, obstruction) or contribute to bowel dysfunction
• Has evidence of intestinal obstruction
• Has a history of rectal bleeding not due to hemorrhoids or fissures
• Has an active malignancy of any type (participants with a history of successfully treated malignancy >5 years before the scheduled administration of study medication and participants with treated basal or squamous cell cancer may be enrolled)
• Is taking antispasmodics (for example, dicyclomine), antidiarrheals (for example, loperamide), prokinetics (for example, metoclopramide), or locally acting chloride channel activators (for example, lubiprostone)
• Is taking non-opioid medications known to cause constipation (for example, iron sulfate therapy or tricyclic antidepressants)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Other Identifiers

5945-SOIC-12-05

Identifier Type: OTHER

Identifier Source: secondary_id

2402-006

Identifier Type: -

Identifier Source: org_study_id