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
  Purpose

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


Condition Intervention Phase
Constipation
Drug: Active Hydromorphone PR + Active Naloxone PR
Drug: Active Hydromorphone PR + Placebo Naloxone PR
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Mundipharma Research GmbH & Co KG:

Primary Outcome Measures:
  • Bowel Function Measure Average pain scores

Secondary Outcome Measures:
  • Bowel Function Measures Rescue medication use

Estimated Enrollment: 600
Study Start Date: January 2010
Study Completion Date: January 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992576

Locations
Australia, New South Wales
Hunter New England Area Health Service
Newcastle, New South Wales, Australia, 2300
Austria
AKH Wien - Universitätskliniken
Wien, Austria, A-1090
Belgium
Erasme Hospital
Bruxelles, Belgium, 1070
Czech Republic
Poradna pro lecbu bolesti
Pribram, Czech Republic, 261-01
Denmark
Speciallæge Michael Crawford
København K., Denmark, 1100
Finland
Oma Lääkäri Oy
Kuopio, Finland, Fl-70100
France
CHU - Hôpital Amiens Nord
Amiens Cedex 1, France, 80054
Germany
Universitaetsklinikum Jena
Jena, Germany, 07747
Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Netherlands
Diakonessenhuis, locatie Zeist
Zeist, Netherlands, 3707HL
Poland
Szpital Uniwersytecki w Krakowie Zakład Badania
Krakow, Poland, 31-531
Romania
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, Romania, 400006
Switzerland
Kantonsspital Aarau
Aarau, Switzerland, 5001
United Kingdom
Avondale Surgery
Chesterfield, United Kingdom, S40 4TF
Sponsors and Collaborators
Mundipharma Research GmbH & Co KG
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00992576     History of Changes
Other Study ID Numbers: 2008-005312-18
Study First Received: October 6, 2009
Last Updated: February 14, 2012
Health Authority: United States: Food and Drug Administration
Austria: AGES
Australia: TGA,
Belgium: AFMPS;
Czech Republic: SUKL,
Denmark: DKMA,
Finland: NAM,
France: Afssaps,
Germany: BfArM,
Israel: MOH,
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: CEBK,
Romania: NMA,
Switzerland: FOPH,
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Mundipharma Research GmbH & Co KG:
Confirmatory
Constipation
Pain
Hydromorphone
Naloxone

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Hydromorphone
Naloxone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics
Narcotic Antagonists

ClinicalTrials.gov processed this record on April 14, 2014