Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain (HMX3501)

This study has been completed.

Sponsor:

Information provided by:

Mundipharma Research GmbH & Co KG

ClinicalTrials.gov Identifier:

NCT00992576

First received: October 6, 2009

Last updated: February 14, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	October 6, 2009
Last Updated Date	February 14, 2012
Start Date ^ICMJE	January 2010
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 8, 2009)	Bowel Function Measure Average pain scores
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00992576 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 8, 2009)	Bowel Function Measures Rescue medication use
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain
Official Title ^ICMJE	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
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 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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2 Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Constipation
Intervention ^ICMJE	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
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	600
Completion Date	January 2012
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Israel, Netherlands, Poland, Romania, Switzerland, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00992576
Other Study ID Numbers ^ICMJE	2008-005312-18
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Mundipharma Research GmbH & Co KG
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Mundipharma Research GmbH & Co KG
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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