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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00135577




Registration number
NCT00135577
Ethics application status
Date submitted
24/08/2005
Date registered
26/08/2005
Date last updated
2/09/2015

Titles & IDs
Public title
Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
Scientific title
A Double-Blind, Placebo-Controlled, Multicenter Phase IIb Extension Study to Evaluate the Safety and Efficacy of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
Secondary ID [1] 0 0
ABD101684
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Bowel Dysfunction 0 0
Condition category
Condition code
Cancer 0 0 0 0
Any cancer
Mental Health 0 0 0 0
Addiction
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 once in the morning and once in the evening.

Experimental: Alvimopan 1 mg Once Daily (QD) - Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg in the morning and received placebo in the evening.

Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan in the morning and placebo in the evening for 3 days, then 1 mg of alvimopan in the morning and placebo in the evening for the remaining 3 weeks.

Experimental: Alvimopan 1 mg Twice Daily (BID) - Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg once in the morning and once in the evening.

Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan once in the morning and once in the evening for 3 days, then 1 mg of alvimopan once in the morning and once in the evening.

Placebo comparator: Placebo - Placebo was administered orally once in the morning and once in evening.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of reported adverse events, including serious adverse events
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Completed GSK sponsored alvimopan (opioid-induced bowel dysfunction) OBD study for subjects with cancer-related pain, e.g. SB-767905/008.
* Taking full agonist opioid therapy for cancer related pain.
* Met entry criteria of OBD in original study and per investigator continues to require therapy for management of OBD.
* Capable of completing paper questionnaires at the study visits.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to eat or drink.
* Taking opioids for management of drug addiction.
* Unable to use only rescue laxatives provided.
* Inappropriately managed severe constipation that puts subject at risk of complications.
* Has gastrointestinal (GI) or pelvic disorder known to affect bowel transit.
* Concomitant medication(s), medical condition, or clinically significant laboratory abnormality that could jeopardize subject and also contraindicate study participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
1/09/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2007
Sample size
Target
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Washington
Country [8] 0 0
Canada
State/province [8] 0 0
Manitoba
Country [9] 0 0
Canada
State/province [9] 0 0
Newfoundland and Labrador
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Finland
State/province [12] 0 0
Helsinki
Country [13] 0 0
France
State/province [13] 0 0
Bordeaux Cedex
Country [14] 0 0
France
State/province [14] 0 0
Strasbourg
Country [15] 0 0
France
State/province [15] 0 0
Vandoeuvre-Les-Nancy
Country [16] 0 0
France
State/province [16] 0 0
Villejuif Cedex
Country [17] 0 0
Hong Kong
State/province [17] 0 0
Kwun Tong
Country [18] 0 0
New Zealand
State/province [18] 0 0
Wellington
Country [19] 0 0
Pakistan
State/province [19] 0 0
Lahore
Country [20] 0 0
Peru
State/province [20] 0 0
Lima
Country [21] 0 0
Poland
State/province [21] 0 0
Bialystok
Country [22] 0 0
Poland
State/province [22] 0 0
Lublin
Country [23] 0 0
Poland
State/province [23] 0 0
Olsztyn
Country [24] 0 0
Poland
State/province [24] 0 0
Otwock
Country [25] 0 0
Poland
State/province [25] 0 0
Poznan
Country [26] 0 0
Portugal
State/province [26] 0 0
Lisboa
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Moscow
Country [28] 0 0
Spain
State/province [28] 0 0
Alcorcon
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Nottingham

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
Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants with cancer pain.

Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.
Trial website
https://clinicaltrials.gov/study/NCT00135577
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/NCT00135577