NCT00992576

Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain

A Confirmatory, Placebo-controlled, Randomised, Double-blind, Single-dummy, Parallel Group, Ratio-finding Study in Constipated Pain Patients to Establish an Optimal Hydromorphone - Naloxone Ratio With an Improved Bowel Function and a Comparable Analgesic Efficacy Compared to Hydromorphone Alone

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Mundipharma Research GmbH & Co KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an improved bowel function for constipated pain patients.

Detailed description

Subjects suffering from cancer or non-cancer pain suffering from constipation cased or aggravated by opioids will be randomised to one of four ratios of hydromorphone PR plus naloxone PR or Hydromorphone PR plus placebo to investigate whether a hydromorphone/naloxone combination will lead to comparable analgesia, with a decrease in constipation, and to investigate the optimal dose ratio of hydromorphone and naloxone.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	Active Hydromorphone PR + Active Naloxone PR	Optimal pain relief and improved bowel function in constipated pain patients
DRUG	Active Hydromorphone PR + Placebo Naloxone PR	Optimal pain relief and improved bowel function in constipated pain patients

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-11-01
• Completion: 2012-01-01
• First posted: 2009-10-09
• Last updated: 2012-02-15

Locations

14 sites across 14 countries: Australia, Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Israel, Netherlands, Poland, Romania, Switzerland, United Kingdom