Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain
Information source: Mundipharma Research GmbH & Co KG
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Constipation
Intervention: Active Hydromorphone PR + Active Naloxone PR (Drug); Active Hydromorphone PR + Placebo Naloxone PR (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Mundipharma Research GmbH & Co KG Overall contact:
Margaret C Wilson, Email: info@contact-clinical-trials.com
Summary
The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an
improved bowel function for constipated pain patients.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: Bowel Function Measure Average pain scores
Secondary outcome: Bowel Function Measures Rescue medication use
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Margaret C Wilson, Email: info@contact-clinical-trials.com
AKH Wien - Universitätskliniken, Wien A-1090, Austria; Recruiting
Erasme Hospital, Bruxelles 1070, Belgium; Recruiting
Poradna pro lecbu bolesti, Pribram 261-01, Czech Republic; Recruiting
Speciallæge Michael Crawford, København K. 1100, Denmark; Recruiting
Oma Lääkäri Oy, Kuopio Fl-70100, Finland; Recruiting
CHU - Hôpital Amiens Nord, Amiens Cedex 1 80054, France; Recruiting
Universitaetsklinikum Jena, Jena 07747, Germany; Recruiting
Tel-Aviv Sourasky Medical Center, Tel Aviv 64239, Israel; Recruiting
Diakonessenhuis, locatie Zeist, Zeist 3707HL, Netherlands; Recruiting
Szpital Uniwersytecki w Krakowie Zakład Badania, Krakow 31-531, Poland; Recruiting
Spitalul Clinic Judetean de Urgenta Cluj, Cluj-Napoca 400006, Romania; Recruiting
Kantonsspital Aarau, Aarau 5001, Switzerland; Recruiting
Avondale Surgery, Chesterfield S40 4TF, United Kingdom; Recruiting
Hunter New England Area Health Service, Newcastle, New South Wales 2300, Australia; Recruiting
Additional Information
Starting date: October 2009
Last updated: August 16, 2010
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