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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00331045
• Other study ID #: ABD102965
• Status: Terminated
• Phase: Phase 2
• First received: May 26, 2006
• Last updated: September 1, 2015
• Start date: April 2006
• Est. completion date: December 2006

Study information

• Verified date: September 2009
• Source: Cubist Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Constipation

Intervention

Drug:
• alvimopan
0.25 mg/day
• Placebo

• Alvimopan 0.5 mg/day

• Alvimopan 1 mg/day

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cubist Pharmaceuticals LLC	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of responders for OBD global improvement Changes in weekly subjective bowel movement symptoms Changes in weekly constipation symptoms questionnaire