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Trial registered on ANZCTR


Registration number
ACTRN12605000696695
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
28/10/2005
Date last updated
15/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Double-blind, Double-dummy, Randomised, Parallel-Arm Equivalence [Non-Inferiority] Study Comparing Hydromorphone Hydrochloride Extended-Release [HHER] Capsules to MS Contin Tablets, Dosed at a Ratio of 1:7.5 to relieve pain, in Cancer or Non-Cancer Patients with a History of Moderate to Severe Pain
Scientific title
Double-blind, Double-dummy, Randomised, Parallel-Arm Equivalence [Non-Inferiority] Study Comparing Hydromorphone Hydrochloride Extended-Release [HHER] Capsules to MS Contin Tablets, Dosed at a Ratio of 1:7.5 to relieve pain, in Cancer or Non-Cancer Patients with a History of Moderate to Severe Pain
Secondary ID [1] 207 0
Hunter Area Health Service: HMP3801
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to severe pain 845 0
Condition category
Condition code
Neurological 912 912 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with a history of moderate to severe pain [and who have poorly controlled pain] will be randomised to receive either HHER or MS Contin for 7 [+2] days. Aim is to establish that HHER and MS Contin are equivalent [non-inferior] at an equianalgesic dose ratio of 1:7.5
Intervention code [1] 571 0
Treatment: Drugs
Comparator / control treatment
Comparing Hydromorphone Hydrochloride Extended-Release [HHER] Capsules to MS Contin Tablets, Dosed at a Ratio of 1:7.5
Control group
Active

Outcomes
Primary outcome [1] 1187 0
Average daily pain scores for the 7-day double-blind treatment phase using BS-11 scale
Timepoint [1] 1187 0
Assessed on a daily basis throughout the 7 day treatment phase.
Secondary outcome [1] 2172 0
Total daily dose of study medication and rescue medication.
Timepoint [1] 2172 0
Assessed at the end of the trial by totalling the daily dose of the study medication taken by each patient.
Secondary outcome [2] 2173 0
Acceptability of treatment and global assessment.
Timepoint [2] 2173 0
Assessed at the end of the trial

Eligibility
Key inclusion criteria
1. Treatment with opioid analgesic for at least past 4 weeks. 2. Prior opioid analgesic equivalent to 80mg morphine or greater. 3. Pain score less than, or equal to, 4 over 24 hour period for last two consecutive days. 4. Rescue doses less than, or equal to, three doses over 24 hour period for the last two consecutive days.
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of alcohol or drug abuse, unstable pain, high dose systemic corticosteroid therapy excluded.

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)
Double-dummy study design. Investigator and staff, patients and clinical monitors blinded to block size and to double-blind treatment randomisation. Stabilisation and rescue medication not blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients successfully completing stabilisation are randomised to receive either HHER or MS Contin. Equal number of each of the two treatment groups [test or reference medication] in each block of randomisation numbers [determined by statistician]. Each study centre assigns individual patients a double-blind randomisation number [and corresponding study medication] in ascending and sequential order.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1007 0
Commercial sector/Industry
Name [1] 1007 0
Mundipharma Pty Limited
Address [1] 1007 0
50 Bridge Street,
Sydney, NSW 2000
Country [1] 1007 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Mundipharma Pty Limited
Address
50 Bridge Street,
Sydney, NSW 2000
Country
Australia
Secondary sponsor category [1] 868 0
None
Name [1] 868 0
None
Address [1] 868 0
Country [1] 868 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This is a double-blind, double-dummy, randomised, parallel-arm controlle trial of HHER and MS Contin in patients with a history of chronic moderate to severe cancer or non-cancer pain.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 36382 0
Prof Michael Cousins
Address 36382 0
Pain Management Research Institute
Level 5, Royal North Shore Hospital
St Leonards, NSW 2065
Country 36382 0
Australia
Phone 36382 0
N/A
Fax 36382 0
Email 36382 0
mcousins@nsccahs.health.nsw.gov.au
Contact person for public queries
Name 9760 0
Dr Christine Smith
Address 9760 0
Director Medical Affairs Mundipharma Pty Limited 50 Bridge Street Sydney NSW 2000
Country 9760 0
Australia
Phone 9760 0
+61 2 92317215
Fax 9760 0
+61 2 92230011
Email 9760 0
christine.smith@mundipharma.com.au
Contact person for scientific queries
Name 688 0
Dr Christine Smith
Address 688 0
Director Medical Affairs Mundipharma Pty Limited 50 Bridge Street Sydney NSW 2000
Country 688 0
Australia
Phone 688 0
+61 2 92317215
Fax 688 0
+61 2 92230011
Email 688 0
christine.smith@mundipharma.com.au

No information has been provided regarding IPD availability
Summary results
No Results