Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00992576




Registration number
NCT00992576
Ethics application status
Date submitted
6/10/2009
Date registered
9/10/2009
Date last updated
15/02/2012

Titles & IDs
Public title
Optimisation of Hydromorphone - Naloxone Ratio for the Treatment of Pain
Scientific 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
Secondary ID [1] 0 0
2008-005312-18
Universal Trial Number (UTN)
Trial acronym
HMX3501
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constipation 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Active Hydromorphone PR + Active Naloxone PR
Treatment: Drugs - Active Hydromorphone PR + Placebo Naloxone PR

Treatment: Drugs: Active Hydromorphone PR + Active Naloxone PR
Optimal pain relief and improved bowel function in constipated pain patients

Treatment: Drugs: Active Hydromorphone PR + Placebo Naloxone PR
Optimal pain relief and improved bowel function in constipated pain patients
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bowel Function Measure Average pain scores
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Bowel Function Measures Rescue medication use
Timepoint [1] 0 0

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2012
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Hunter New England Area Health Service - Newcastle
Recruitment postcode(s) [1] 0 0
2300 - Newcastle
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Belgium
State/province [2] 0 0
Bruxelles
Country [3] 0 0
Czech Republic
State/province [3] 0 0
Pribram
Country [4] 0 0
Denmark
State/province [4] 0 0
København K.
Country [5] 0 0
Finland
State/province [5] 0 0
Kuopio
Country [6] 0 0
France
State/province [6] 0 0
Amiens Cedex 1
Country [7] 0 0
Germany
State/province [7] 0 0
Jena
Country [8] 0 0
Israel
State/province [8] 0 0
Tel Aviv
Country [9] 0 0
Netherlands
State/province [9] 0 0
Zeist
Country [10] 0 0
Poland
State/province [10] 0 0
Krakow
Country [11] 0 0
Romania
State/province [11] 0 0
Cluj-Napoca
Country [12] 0 0
Switzerland
State/province [12] 0 0
Aarau
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Chesterfield

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mundipharma Research GmbH & Co KG
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT00992576
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00992576