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

October 6, 2009
February 14, 2012
January 2010
November 2011   (final data collection date for primary outcome measure)
Bowel Function Measure Average pain scores
Same as current
Complete list of historical versions of study NCT00992576 on ClinicalTrials.gov Archive Site
Bowel Function Measures Rescue medication use
Same as current
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Constipation
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
January 2012
November 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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).
  2. Subjects with constipation caused or aggravated by opioids
  3. Subjects must be willing to discontinue their current opioid analgesic routine, and .
  4. current laxative regimen

Exclusion Criteria:

  1. Chronic or intermittent pain that results from Fibromyalgia or Rheumatoid Arthritis.
  2. Subjects presently taking, or who have taken, naloxone <=30 days prior to the start of the Screening Period.
  3. Subjects suffering from diarrhoea.
  4. Abnormal liver or kidney function.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   United Kingdom,   France,   Netherlands,   Belgium,   Australia,   Switzerland,   Finland,   Czech Republic,   Denmark,   Romania,   Poland,   Israel,   Germany
 
NCT00992576
2008-005312-18
Not Provided
Not Provided
Mundipharma Research GmbH & Co KG
Not Provided
Not Provided
Mundipharma Research GmbH & Co KG
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP