Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain (HMX3501)
This study has been completed.
Sponsor:
Mundipharma Research GmbH & Co KG
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
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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:
Detailed Description:
-
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
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:
- 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.
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 May 22, 2013