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Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00241722
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : August 30, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Tracking Information
First Submitted Date  ICMJE October 17, 2005
First Posted Date  ICMJE October 19, 2005
Last Update Posted Date August 30, 2017
Actual Study Start Date  ICMJE August 1, 2005
Actual Primary Completion Date February 1, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2007)
To compare alvimopan with placebo for long-term safety and tolerability [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2005)
To compare alvimopan with placebo for long-term safety and tolerability
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2007)
Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data) [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2005)
- quality of life - pharmacokinetics - pharmacogenetics (dependent on results from other data)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate Long-Term Safety and Efficacy of Alvimopan 0.5mg Twice Daily for 12 Months for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain
Brief Summary Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The primary objective of this Phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. Participants will be required to attend 8 clinic visits over approximately 1 year.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Bowel Dysfunction
  • Constipation
Intervention  ICMJE
  • Drug: Alvimopan
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Alvimopan 0.5 mg Twice Daily (BID)
    0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.
    Intervention: Drug: Alvimopan
  • Placebo Comparator: Placebo
    Placebo was administered orally BID for 12 months.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2015)
805
Original Enrollment  ICMJE
 (submitted: October 17, 2005)
750
Actual Study Completion Date  ICMJE February 1, 2007
Actual Primary Completion Date February 1, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Consented to participate in this study.
  • Taking opioid therapy for persistent non-cancer pain.
  • Has bowel dysfunction mainly due to opioids.
  • Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms.
  • Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed).

Exclusion criteria:

  • Pregnant, lactating, or planning to become pregnant.
  • Not ambulatory.
  • Participated in another trial with an investigational drug in the past 30 days.
  • Taking opioids for the management of drug addiction or cancer-related pain.
  • Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation.
  • Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
  • Human Immunodeficiency Virus (HIV)-infected, has active hepatitis, or has ever been infected with hepatitis C.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   Denmark,   Finland,   Hong Kong,   Hungary,   Ireland,   Netherlands,   New Zealand,   Poland,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT00241722
Other Study ID Numbers  ICMJE 3753-013
SB-767905/014 ( Other Identifier: Cubist Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cubist Pharmaceuticals LLC
Study Sponsor  ICMJE Cubist Pharmaceuticals LLC
Collaborators  ICMJE GlaxoSmithKline
Investigators  ICMJE
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
PRS Account Cubist Pharmaceuticals LLC
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP