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

NCT01696643 | Terminated Phase 3 Results

• 2 other identifiers: 2402-0065945-SOIC-12-05
• Study Type: interventional
• Target: 1,407
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opioid-Induced Constipation

Keywords

Opioid; Constipation; Chronic; Pain

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

  A TEAE was defined as any adverse event (AE) that occurred from the time of first dose of the study drug through the last study evaluation or pre-existing AEs that were aggravated in severity or frequency during the dosing period. The percentages of participants with at least 1 TEAE, with at least 1 drug-related TEAE (drug-related included "possibly related" or "related" as deemed by the Investigator; it also included events if causality was missing), and who discontinued from treatment due to a TEAE are presented. A summary of serious and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.

  Baseline through Week 56

Secondary Outcomes (4)

• Change From Baseline in Mean Daily Opioid Dose at Weeks 49-52

  Baseline, Weeks 49-52

• Change From Baseline in Patient Assessment of Constipation-Quality of Life (PAC-QOL) Questionnaire at Week 52

  Baseline, Week 52

• Change From Baseline in Patient-Reported Constipation Severity Assessment (PCSA) at Week 52

  Baseline, Week 52

• Plasma Trough Concentrations of CB-5945

  Weeks 4, 12, 24, 36, and 52

Other Outcomes (1)

• Number of Participants With Adjudicated Cardiovascular, Gastrointestinal, or Central Opioid Withdrawal Events

  Baseline through Week 56

Study Arms (2)

CB-5945

EXPERIMENTAL

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

Drug: CB-5945

Placebo

PLACEBO COMPARATOR

Placebo, administered orally, BID for 52 weeks

Drug: Placebo

Interventions

CB-5945 DRUG

Also known as: Bevenopran

CB-5945

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

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

MeSH Terms

Conditions

Opioid-Induced Constipation; Constipation; Bronchiolitis Obliterans Syndrome; Pain

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Neurologic Manifestations

Results Point of Contact

• Title: Vice President, Clinical Research
• Organization: Cubist Pharmaceuticals

1.781.860.8660

Study Officials

• Medical Monitor

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: October 1, 2012
• Study Start: October 12, 2012
• Primary Completion: July 21, 2014
• Study Completion: July 21, 2014
• Last Updated: November 15, 2018
• Results First Posted: September 28, 2015

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share