Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain

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

Detailed Description
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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.

Official Title
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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

Conditions
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Constipation

Intervention / Treatment
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* Drug: Active Hydromorphone PR + Active Naloxone PR
* Drug: Active Hydromorphone PR + Placebo Naloxone PR


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel Function Measure Average pain scores |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bowel Function Measures Rescue medication use |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Confirmatory, Constipation, Pain, Hydromorphone, Naloxone