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

NCT01901302 | Terminated Phase 3 Results DMC

• 2 other identifiers: 2402-0035945-OIC-12-02
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and efficacy 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)

• Overall Spontaneous Bowel Movement (SBM) Responder Rates at 12 Weeks

  A Spontaneous Bowel Movement (SBM) Weekly Responder (calculated for each week of the 12-week double-blind treatment period) is a participant who has ≥ 3 SBMs for the week and an increase from baseline of ≥1 SBM for the specified week, based on at least 4 Available Data Days (ADDs) during the week. A Complete SBM (CSBM) Weekly Responder is a participant who has ≥ 3 CSBMs for the specified week and an increase from baseline of ≥1 CSBM for the week. For the definition of the primary efficacy endpoint, Overall SBM Responder is a participant who is a Weekly SBM Responder for 9 of the 12 weeks of the double-blind treatment period, including 3 of the last 4 weeks (Weeks 9, 10, 11 and 12).

  12 weeks

Secondary Outcomes (2)

• Change From Baseline of Chronic Opioid-Related Gastrointestinal Symptom Scale (CORGISS) Scores at 12 Weeks

  Baseline, 12 weeks

• Overall Complete Spontaneous Bowel Movement (CSBM) Responder Rates at 12 Weeks

  12 weeks

Other Outcomes (1)

• Adjudicated Cardiovascular, Gastrointestinal and Central Opioid Withdrawal Events

  Baseline through 16 weeks

Study Arms (2)

CB-5945

EXPERIMENTAL

0.25 milligrams (mg) CB-5945 administered orally twice daily (BID) for a 12-week treatment period

Drug: CB-5945

Placebo

PLACEBO COMPARATOR

Placebo BID for a 12-week treatment period

Drug: Placebo

Interventions

CB-5945 DRUG

Also known as: Bevenopran, ADL5945

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 (e.g., lubiprostone) from Screening until the last study assessment

You may not qualify if:

• Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for example \[e.g.\], obstruction) or contribute to bowel dysfunction
• Has evidence of intestinal obstruction
• Has a history of rectal bleeding not due to hemorrhoids or fissures within 6 months of screening
• 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 (e.g., dicyclomine), antidiarrheals (e.g., loperamide), prokinetics (e.g., metoclopramide), or locally acting chloride channel activators (e.g., lubiprostone)
• Is taking non-opioid medications known to cause constipation (e.g., iron sulfate therapy, 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

Limitations and Caveats

Due to difficulties with enrollment, this study was terminated early.

Results Point of Contact

• Title: Vice President Clinical Research
• Organization: Cubist Pharamceuticals

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: July 9, 2013
• First Posted: July 17, 2013
• Study Start: May 20, 2013
• Primary Completion: February 13, 2014
• Study Completion: February 13, 2014
• Last Updated: November 15, 2018
• Results First Posted: July 2, 2015

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share