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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00259922
Registration number
NCT00259922
Ethics application status
Date submitted
29/11/2005
Date registered
1/12/2005
Date last updated
2/09/2015
Titles & IDs
Public title
Alvimopan For The Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain
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Secondary ID [1]
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SB-767905/013
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bowel Dysfunction
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Constipation
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Alvimopan
Treatment: Drugs - Alviompan
Placebo comparator: Placebo -
Experimental: Alvimopan 0.5 mg once daily - 0.5 mg once daily (QD)
Experimental: Alvimopan 0.5 mg twice daily - 0.5 mg twice daily (BID)
Treatment: Drugs: Placebo
Placebo
Treatment: Drugs: Alvimopan
0.5 mg QD
Treatment: Drugs: Alviompan
0.5 mg BID
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To compare alvimopan with placebo for efficacy in the treatment of OBD
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Safety and tolerability, quality of life, pharmacogenetics (dependent on results from other data)
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
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).
* Willing to report daily bowel symptoms.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
* HIV-infected, has active hepatitis, or has ever been infected with hepatitis C.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2005
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Date of last participant enrolment
Anticipated
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Actual
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Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
485
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Broadmeadow
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GSK Investigational Site - Nedlands
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2292 - Broadmeadow
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2300 - Newcastle
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2065 - St Leonards
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4152 - Carina Heights
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4021 - Kippa Ring
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5042 - Bedford Park
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5606 - Port Lincoln
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5065 - Toorak Gardens
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3128 - Box Hill
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3053 - Carlton
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6160 - Fremantle
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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GlaxoSmithKline
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Ethics approval
Ethics application status
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Summary
Brief summary
Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.
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Trial website
https://clinicaltrials.gov/study/NCT00259922
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Trial related presentations / publications
Irving G, Penzes J, Ramjattan B, Cousins M, Rauck R, Spierings EL, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/013) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. J Pain. 2011 Feb;12(2):175-84. doi: 10.1016/j.jpain.2010.06.013.
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials, MD
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Address
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GlaxoSmithKline
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Irving G, Penzes J, Ramjattan B, Cousins M, Rauck ...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00259922
Download to PDF