Clinical Evaluation Of Alvimopan (SB767905) On Constipation And Related Symptoms Associated With Opioid

Clinical Evaluation of Alvimopan (SB767905) on Constipation and Related Symptoms Associated With Opioid -A Placebo-controlled Double-blind Study in Cancer Patients-

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00331045

Enrollment

Registered

2006-05-29

Start date

2006-04-30

Completion date

2006-12-31

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

Cancer, Constipation

Keywords

Opioids, cancer, constipation

Brief summary

This study is intended to investigate the recommended dose of alvimopan in doses 0.25mg/day (0.25mg, OD), 0.5mg/day (0.25mg, BID) or 1mg/day (0.5mg, BID) or placebo for 3 weeks in patients who receive opioids for the management of cancer pain and develop constipation, by giving overall consideration to the efficacy and safety data in each treatment group. Also, efficacy and safety data of alvimopan in the recommended dose group will be compared with those of placebo and to confirm alvimopan's safety and efficacy.

Interventions

DRUGalvimopan

0.25 mg/day

DRUGPlacebo

DRUGAlvimopan 0.5 mg/day

DRUGAlvimopan 1 mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Have cancer. * Taking opioid therapy for continued intractable pain. * Experiencing less bowel movement frequency compared to that before the opioid treatment. * Must meet the protocol-definition of opioid-induced constipation.

Exclusion criteria

* Gastrointestinal or pelvic disorders known to affect gastrointestinal functions or induce bowel transit disorder and ileus. * Subjects, who in the investigator's opinion, have gastrointestinal dysfunction predominantly due to causes other than the use of opioids.

Design outcomes

Primary

Measure	Time frame
Change from baseline during the 1-week Pre-Treatment Period in average weekly bowel movement with no rescue laxative use in the previous 24 hours Frequency during the 3-week Treatment Period	—

Secondary

Measure	Time frame
Proportion of responders for OBD global improvement Changes in weekly subjective bowel movement symptoms Changes in weekly constipation symptoms questionnaire	—

Outcome results

None listed

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