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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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
Secondary ID [1] 0 0
SB-767905/013
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel Dysfunction 0 0
Constipation 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare alvimopan with placebo for efficacy in the treatment of OBD
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Safety and tolerability, quality of life, pharmacogenetics (dependent on results from other data)
Timepoint [1] 0 0

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
485
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Broadmeadow
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GSK Investigational Site - Newcastle
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GSK Investigational Site - St Leonards
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GSK Investigational Site - Carina Heights
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GSK Investigational Site - Kippa Ring
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GSK Investigational Site - Bedford Park
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GSK Investigational Site - Port Lincoln
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GSK Investigational Site - Toorak Gardens
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GSK Investigational Site - Box Hill
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GSK Investigational Site - Carlton
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GSK Investigational Site - Fremantle
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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
Recruitment outside Australia
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Nottwil

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
GlaxoSmithKline
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00259922
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials, MD
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00259922