Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain
HMX3501
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
1 other identifier
interventional
600
13 countries
13
Brief Summary
The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an improved bowel function for constipated pain patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2010
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2009
CompletedFirst Posted
Study publicly available on registry
October 9, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFebruary 15, 2012
February 1, 2012
1.8 years
October 6, 2009
February 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bowel Function Measure Average pain scores
Secondary Outcomes (1)
Bowel Function Measures Rescue medication use
Interventions
Optimal pain relief and improved bowel function in constipated pain patients
Optimal pain relief and improved bowel function in constipated pain patients
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Hunter New England Area Health Service
Newcastle, New South Wales, 2300, Australia
AKH Wien - Universitätskliniken
Vienna, A-1090, Austria
Erasme Hospital
Brussels, 1070, Belgium
Poradna pro lecbu bolesti
Příbram, 261-01, Czechia
Speciallæge Michael Crawford
København K., 1100, Denmark
Oma Lääkäri Oy
Kuopio, Fl-70100, Finland
CHU - Hôpital Amiens Nord
Amiens, 80054, France
Universitaetsklinikum Jena
Jena, 07747, Germany
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Diakonessenhuis, locatie Zeist
Zeist, 3707HL, Netherlands
Szpital Uniwersytecki w Krakowie Zakład Badania
Krakow, 31-531, Poland
Spitalul Clinic Judetean de Urgenta Cluj
Cluj-Napoca, 400006, Romania
Kantonsspital Aarau
Aarau, 5001, Switzerland
Avondale Surgery
Chesterfield, S40 4TF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 6, 2009
First Posted
October 9, 2009
Study Start
January 1, 2010
Primary Completion
November 1, 2011
Study Completion
January 1, 2012
Last Updated
February 15, 2012
Record last verified: 2012-02