Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00241722




Registration number
NCT00241722
Ethics application status
Date submitted
17/10/2005
Date registered
19/10/2005
Date last updated
30/08/2017

Titles & IDs
Public title
Long-Term Safety Evaluation Of 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 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
Secondary ID [1] 0 0
SB-767905/014
Secondary ID [2] 0 0
3753-013
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
Experimental: Alvimopan 0.5 mg Twice Daily (BID) - 0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.

Placebo comparator: Placebo - Placebo was administered orally BID for 12 months.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To compare alvimopan with placebo for long-term safety and tolerability
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)
Timepoint [1] 0 0
12 months

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).
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.
* Human Immunodeficiency Virus (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
1/02/2007
Sample size
Target
Accrual to date
Final
805
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Broadmeadow
Recruitment hospital [2] 0 0
GSK Investigational Site - St Leonards
Recruitment hospital [3] 0 0
GSK Investigational Site - Carina Heights
Recruitment hospital [4] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [5] 0 0
GSK Investigational Site - Bedford Park
Recruitment hospital [6] 0 0
GSK Investigational Site - Port Lincoln
Recruitment hospital [7] 0 0
GSK Investigational Site - Toorak Gardens
Recruitment hospital [8] 0 0
GSK Investigational Site - Box Hill
Recruitment hospital [9] 0 0
GSK Investigational Site - Carlton
Recruitment hospital [10] 0 0
GSK Investigational Site - Fremantle
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4152 - Carina Heights
Recruitment postcode(s) [4] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
5606 - Port Lincoln
Recruitment postcode(s) [7] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3053 - Carlton
Recruitment postcode(s) [10] 0 0
6160 - Fremantle
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Montana
Country [20] 0 0
United States of America
State/province [20] 0 0
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
Nevada
Country [22] 0 0
United States of America
State/province [22] 0 0
New Hampshire
Country [23] 0 0
United States of America
State/province [23] 0 0
New Jersey
Country [24] 0 0
United States of America
State/province [24] 0 0
New Mexico
Country [25] 0 0
United States of America
State/province [25] 0 0
New York
Country [26] 0 0
United States of America
State/province [26] 0 0
North Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Ohio
Country [28] 0 0
United States of America
State/province [28] 0 0
Oklahoma
Country [29] 0 0
United States of America
State/province [29] 0 0
Oregon
Country [30] 0 0
United States of America
State/province [30] 0 0
Pennsylvania
Country [31] 0 0
United States of America
State/province [31] 0 0
Rhode Island
Country [32] 0 0
United States of America
State/province [32] 0 0
Tennessee
Country [33] 0 0
United States of America
State/province [33] 0 0
Texas
Country [34] 0 0
United States of America
State/province [34] 0 0
Utah
Country [35] 0 0
United States of America
State/province [35] 0 0
Virginia
Country [36] 0 0
United States of America
State/province [36] 0 0
Washington
Country [37] 0 0
United States of America
State/province [37] 0 0
West Virginia
Country [38] 0 0
Austria
State/province [38] 0 0
Vienna
Country [39] 0 0
Canada
State/province [39] 0 0
Alberta
Country [40] 0 0
Canada
State/province [40] 0 0
British Columbia
Country [41] 0 0
Canada
State/province [41] 0 0
Manitoba
Country [42] 0 0
Canada
State/province [42] 0 0
New Brunswick
Country [43] 0 0
Canada
State/province [43] 0 0
Newfoundland and Labrador
Country [44] 0 0
Canada
State/province [44] 0 0
Nova Scotia
Country [45] 0 0
Canada
State/province [45] 0 0
Ontario
Country [46] 0 0
Canada
State/province [46] 0 0
Prince Edward Island
Country [47] 0 0
Canada
State/province [47] 0 0
Quebec
Country [48] 0 0
Denmark
State/province [48] 0 0
Ishoj
Country [49] 0 0
Finland
State/province [49] 0 0
Helsinki
Country [50] 0 0
Hong Kong
State/province [50] 0 0
Kowloon
Country [51] 0 0
Hong Kong
State/province [51] 0 0
Kwun Tong
Country [52] 0 0
Hong Kong
State/province [52] 0 0
Pokfulam
Country [53] 0 0
Hong Kong
State/province [53] 0 0
Shatin
Country [54] 0 0
Hungary
State/province [54] 0 0
Budapest
Country [55] 0 0
Ireland
State/province [55] 0 0
Cork
Country [56] 0 0
Netherlands
State/province [56] 0 0
Roosendaal
Country [57] 0 0
Netherlands
State/province [57] 0 0
Utrecht
Country [58] 0 0
New Zealand
State/province [58] 0 0
Christchurch
Country [59] 0 0
New Zealand
State/province [59] 0 0
Hamilton
Country [60] 0 0
New Zealand
State/province [60] 0 0
Tauranga
Country [61] 0 0
Poland
State/province [61] 0 0
Gdansk
Country [62] 0 0
Poland
State/province [62] 0 0
Krakow
Country [63] 0 0
Poland
State/province [63] 0 0
Wroclaw
Country [64] 0 0
Spain
State/province [64] 0 0
Alcorcon
Country [65] 0 0
Spain
State/province [65] 0 0
Barcelona
Country [66] 0 0
Spain
State/province [66] 0 0
El Ferrol
Country [67] 0 0
Spain
State/province [67] 0 0
Granada
Country [68] 0 0
Spain
State/province [68] 0 0
Madrid
Country [69] 0 0
Spain
State/province [69] 0 0
Santander
Country [70] 0 0
Spain
State/province [70] 0 0
Valencia
Country [71] 0 0
Sweden
State/province [71] 0 0
Jönköping
Country [72] 0 0
Sweden
State/province [72] 0 0
Karlstad
Country [73] 0 0
Sweden
State/province [73] 0 0
Linköping
Country [74] 0 0
Sweden
State/province [74] 0 0
Stockholm
Country [75] 0 0
Switzerland
State/province [75] 0 0
Bern
Country [76] 0 0
Taiwan
State/province [76] 0 0
Tainan
Country [77] 0 0
Taiwan
State/province [77] 0 0
Taipei
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Berkshire
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Glamorgan
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Lanarkshire
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Middlesex
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Warwickshire
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Bexhill-on-Sea, East Sussex
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Leeds
Country [85] 0 0
United Kingdom
State/province [85] 0 0
London
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Yaxley, Peterborough

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) 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.
Trial website
https://clinicaltrials.gov/study/NCT00241722
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/study/NCT00241722