Status:
COMPLETED
Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain
Lead Sponsor:
Mundipharma Research GmbH & Co KG
Conditions:
Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 Hydromorph...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2012
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00992576
Start Date
January 1 2010
End Date
January 1 2012
Last Update
February 15 2012
Active Locations (14)
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1
Hunter New England Area Health Service
Newcastle, New South Wales, Australia, 2300
2
AKH Wien - Universitätskliniken
Vienna, Austria, A-1090
3
Erasme Hospital
Brussels, Belgium, 1070
4
Poradna pro lecbu bolesti
Příbram, Czechia, 261-01