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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00135577

Enrollment

Registered

2005-08-26

Start date

2004-09-30

Completion date

2007-04-30

Last updated

2015-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Dysfunction, Cancer

Keywords

opioids, constipation, opioid-induced bowel dysfunction

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.

Interventions

DRUGalvimopan

DRUGplacebo

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Incidence of reported adverse events, including serious adverse events	—

Secondary

Measure	Time frame
Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures	—

Countries

Canada, Finland, France, Hong Kong, New Zealand, Pakistan, Peru, Poland, Portugal, Russia, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026