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Completed

NCT Number: NCT00992576

Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain

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

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Key information

Conditions

Constipation Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hunter New England Area Health Service, Newcastle, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects at least 18 years with a history of non-cancer or cancer pain that requires around-the-clock opioid therapy (8, 24 or 48 mg hydromorphone PR per day for the duration of the study).
  • Subjects with constipation caused or aggravated by opioids
  • Subjects must be willing to discontinue their current opioid analgesic routine, and .
  • current laxative regimen

Exclusion criteria

  • Chronic or intermittent pain that results from Fibromyalgia or Rheumatoid Arthritis.
  • Subjects presently taking, or who have taken, naloxone <=30 days prior to the start of the Screening Period.
  • Subjects suffering from diarrhoea.
  • Abnormal liver or kidney function.

Treatment and study plan

Active Hydromorphone PR + Active Naloxone PR

Drug

Optimal pain relief and improved bowel function in constipated pain patients

Active Hydromorphone PR + Placebo Naloxone PR

Drug

Optimal pain relief and improved bowel function in constipated pain patients

Primary outcomes

  1. Bowel Function Measure Average pain scores

Secondary outcomes

  1. Bowel Function Measures Rescue medication use

Sponsors and collaborators

Lead sponsor

Mundipharma Research GmbH & Co KG

Industry

Registry information

Official study title

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

Acronym: HMX3501

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Oct 9, 2009
Registry last updated
Feb 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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