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

This study is currently recruiting participants.
Verified March 2013 by Cubist Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01696643
First received: September 21, 2012
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Opioid-Induced Constipation
 Drug: CB-5945
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Cubist Pharmaceuticals:

Primary Outcome Measures:
  • Safety and Tolerability of CB-5945 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    The Safety and Tolerability of CB-5945 will be evaluated 0.25 mg twice a day (BID) over 12 months, relative to placebo

    Incidence of adverse events and serious adverse events



Secondary Outcome Measures:
  • Mean daily opioid dose [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life (QOL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The evaluation of the effects of CB-5945 on quality of life (QOL) measurements relative to placebo

  • Constipation severity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluation of the effects of CB-5945 on constipation severity relative to placebo

  • Plasma Trough Concentrations of CB-5945 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Determination of the plasma trough concentrations of CB-5945.


Estimated Enrollment: 1400
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CB-5945 Drug: CB-5945
0.25 mg CB-5945 BID for 52-week treatment period
Placebo Comparator: Placebo Drug: Placebo
Placebo BID for 52-week treatment period

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is taking a stable daily dose of opioids of ≥ 30-mg morphine-equivalent total daily dose (METDD) for chronic non-cancer pain
  2. Has constipation that is caused by the chronic use of opioids
  3. 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) during the study period (from Screening until the last study assessment).
  4. Is able and willing to refrain from facilitating defecation via manual maneuvers (e.g., digital evacuation, support of the pelvic floor) from Screening to the last study assessment

Exclusion Criteria:

  1. Has gastrointestinal (GI) or pelvic disorders known to affect bowel transit (e.g., obstruction) or contribute to bowel dysfunction
  2. Has evidence of intestinal obstruction
  3. Has a history of rectal bleeding not due to hemorrhoids or fissures
  4. Has an active malignancy of any type (subjects with a history of successfully treated malignancy > 5 years before the scheduled administration of study medication and subjects with treated basal or squamous cell cancer may be enrolled)
  5. Is taking antispasmodics (e.g., dicyclomine), antidiarrheals (e.g., loperamide), prokinetics (e.g., metoclopramide), or locally acting chloride channel activators (e.g., lubiprostone)
  6. Is taking nonopioid medications known to cause constipation (e.g., iron sulfate therapy, tricyclic antidepressants)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696643

Contacts
Contact: George Tepelenas 416-496-3901 george.tepelenas@incresearch.com
Contact: Heather Bentley 919-257-6652 heather.bentley@incresearch.com

  Show 116 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals
Investigators
Study Director: Medical Monitor Cubist Pharmaceuticals
  More Information

No publications provided

Responsible Party: Cubist Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01696643     History of Changes
Other Study ID Numbers: 5945-SOIC-12-05
Study First Received: September 21, 2012
Last Updated: March 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals:
Opioid
Constipation
Chronic
Pain

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Analgesics, Opioid
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on June 17, 2013