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

Study Description

Brief Summary

Detailed Description

Condition or disease	Intervention/treatment	Phase
Bowel Dysfunction Cancer	Drug: alvimopan Other Names Drug: placebo Other Names	Phase 2

Tracking Information

First Submitted Date	August 24, 2005
Last Update Posted Date	September 01, 2015
Start Date	September 01, 2004
Actual Completion Date	April 01, 2007
Primary Completion Date	April 01, 2007
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

• Incidence of reported adverse events, including serious adverse events

Original Primary Outcome Measures

Current Secondary Outcome Measures

• Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures

Original Secondary Outcome Measures

Study Design

Brief Title	Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects
Official 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
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.
Detailed Description
Study Type	Interventional
Study Phase	Phase 2
Estimated Enrollment	67
Allocation	Non-Randomized
Interventional Model	Parallel Assignment
Masking	Double
Primary Purpose	Treatment
Conditions	Bowel Dysfunction Cancer
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	Drug: alvimopan Other Names Drug: placebo Other Names
Study Groups/Cohorts	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. 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. 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 Placebo was administered orally once in the morning and once in evening.
Study Arms	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. 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. 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. 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. Drug : alvimopan Placebo Comparator Placebo Placebo was administered orally once in the morning and once in evening. Drug : placebo

Arm	Intervention/Treatment
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.	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.	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.	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.	Drug : alvimopan
Placebo Comparator Placebo Placebo was administered orally once in the morning and once in evening.	Drug : placebo

Recruitment Information

Recruitment Status:	Completed
Enrollment	67
Completion Date	April 01, 2007
Eligibility Criteria:	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.
Gender	All
Age	18 Years to N/A
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	Canada Finland France Hong Kong New Zealand Pakistan Peru Poland Portugal Russian Federation Spain United Kingdom United States Argentina Czech Republic India Korea, Republic of Philippines

Administrative Information

NCT Number:	NCT00135577
Other Study ID Numbers	ABD101684
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Not Available
Responsible Party	,
Study Sponsor	Cubist Pharmaceuticals LLC
Collaborators	GlaxoSmithKline
Investigators	Study Director GSK Clinical Trials, MD GlaxoSmithKline