Suspended

Phase 3 Study to Evaluate the Long-Term Safety and Tolerability of CB-5945 for the Treatment of Opioid-Induced Constipation in Adults Taking Opioid Therapy for Chronic Non-Cancer Pain

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What is being tested

CB-5945

+ Placebo

Drug
Who is being recruted

Narcotic-Related Disorders+19

+ Organizing Pneumonia

+ Mental Disorders

From 18 to 80 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorCubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Last updated: November 15, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: October 12, 2012

Actual date on which the first participant was enrolled.

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.

NCT01696643
Principal SponsorCubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Last updated: November 15, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1407 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Narcotic-Related DisordersOrganizing PneumoniaMental DisordersBronchial DiseasesBronchiolitisBronchiolitis ObliteransBronchitisGraft vs Host DiseaseImmune System DiseasesLung DiseasesLung Diseases, ObstructiveNeurologic ManifestationsRespiratory Tract DiseasesSigns and SymptomsSigns and Symptoms, DigestivePathological Conditions, Signs and SymptomsSubstance-Related DisordersChemically-Induced DisordersOpioid-Induced ConstipationBronchiolitis Obliterans SyndromeConstipationPain

Criteria

4 inclusion criteria required to participate
Has constipation that is caused by the chronic use of opioids
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)
Is taking a stable daily dose of opioids of >= 30-mg morphine-equivalent total daily dose (METDD) for chronic non-cancer pain
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)
6 exclusion criteria prevent from participating
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)
Has evidence of intestinal obstruction
Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (for example, obstruction) or contribute to bowel dysfunction
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Placebo
Placebo, administered orally, BID for 52 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
SuspendedNo study centers