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Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier:
NCT00135577
First received: August 24, 2005
Last updated: September 1, 2015
Last verified: September 2009

August 24, 2005
September 1, 2015
September 2004
April 2007   (final data collection date for primary outcome measure)
Incidence of reported adverse events, including serious adverse events
Same as current
Complete list of historical versions of study NCT00135577 on ClinicalTrials.gov Archive Site
Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures
Same as current
Not Provided
Not Provided
 
Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Cancer
  • Bowel Dysfunction
  • Drug: alvimopan
  • Drug: placebo
  • 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.
    Intervention: Drug: alvimopan
  • 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.

    Interventions:
    • Drug: alvimopan
    • Drug: placebo
  • 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.

    Intervention: Drug: alvimopan
  • Placebo Comparator: Placebo
    Placebo was administered orally once in the morning and once in evening.
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
April 2007
April 2007   (final data collection date for primary outcome measure)

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.

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Finland,   France,   Hong Kong,   New Zealand,   Pakistan,   Peru,   Poland,   Portugal,   Russian Federation,   Spain,   United Kingdom
Argentina,   Czech Republic,   India,   Korea, Republic of,   Philippines
 
NCT00135577
ABD101684
Not Provided
Not Provided
Not Provided
Cubist Pharmaceuticals LLC
Cubist Pharmaceuticals LLC
GlaxoSmithKline
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
Cubist Pharmaceuticals LLC
September 2009

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