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Trial registered on ANZCTR


Registration number
ACTRN12608000242325
Ethics application status
Approved
Date submitted
5/05/2008
Date registered
9/05/2008
Date last updated
5/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Multicentre, Randomised, Double-Blind, Parallel Group Comparison Of The Efficacy And Safety Of Transdermal Buprenorphine (Norspan'registered trade mark' BTDS) And Placebo In Patients With Postherpetic Neuralgia.
Scientific title
A Multicentre, Randomised, Double-Blind, Parallel Group Comparison Of The Efficacy And Safety Of Transdermal Buprenorphine (Norspan'registered trade mark' BTDS) And Placebo In Patients With Postherpetic Neuralgia.
Secondary ID [1] 283082 0
Mundipharma: BUP3026
Universal Trial Number (UTN)
Trial acronym
ASSET PHN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Herpetic Neuralgia 3119 0
Condition category
Condition code
Neurological 3285 3285 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Buprenorphine Transdermal Delivery System (patch applied to the skin), 5, 10, 20, 30, 40 micrograms per hour.
Duration of treatment: maximum of 21 weeks
Intervention code [1] 2865 0
Treatment: Drugs
Comparator / control treatment
Placebo Transdermal Delivery System (placebo patch). The inactive components are the same as the inactive components of the Active treatment.
Duration of treatment: Maximum 21 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 4161 0
Rate of response for pain relief, where response is defined as a 30% reduction in pain using the daily Numerical Rating Scale (NRS). Patients who withdraw will be classified as non-responders.
Timepoint [1] 4161 0
Visit Screening then daily up to Visit Assessment 6.
[Assessment period is 12 weeks (6 fortnightly Visits)]
Secondary outcome [1] 7004 0
Change from baseline in mean categorical scale score for pain intensity.
Timepoint [1] 7004 0
Visit screening,Visit Randomisation, Visit Titration 1 to 6, Visit Assessment 1 to 6.
Secondary outcome [2] 7005 0
Mean categorical scale score for pain relief .
Timepoint [2] 7005 0
Visit screening,Visit Randomisation, Visit Titration 1 to 6, Visit Assessment 1 to 6.
Secondary outcome [3] 7006 0
Change from baseline in weekly NRS and categorical scores for continuous pain, paroxysmal pain and allodynia.
Timepoint [3] 7006 0
Visit Randomisation, Vist Titration 1 to 6, Visit Assesment 1 to 6.
Secondary outcome [4] 7007 0
Differences in total rescue medication usage between active and placebo treatment groups.
Timepoint [4] 7007 0
Visit Randomisation, Visit End Titration and Visit Assessment 6.
Secondary outcome [5] 7008 0
Change in Short-Form McGill Pain Questionnaire (SF-MPQ)
Timepoint [5] 7008 0
Visit Randomisation, Visit end titration and Visit Assessment 6.
Secondary outcome [6] 7009 0
Change in Health-Related Quality of Life (QOL) as measured by SF-36.
Timepoint [6] 7009 0
Visit Randomisation and Visit Assessment 6
Secondary outcome [7] 7010 0
Patient Global Impression of Change Scale (PGIC).
Timepoint [7] 7010 0
Visit Assessment 6
Secondary outcome [8] 7011 0
Clinician Global Impression of Change Scale (CGIC).
Timepoint [8] 7011 0
Visit Assessment 6
Secondary outcome [9] 7032 0
Change in interference by pain in daily activities as measured by Brief Pain Inventory (BPI)
Timepoint [9] 7032 0
Visit Randomisation, Visit End Titration and Visit Assessment 6.
Secondary outcome [10] 7033 0
Change in affective state as measured by Beck Depression Inventory (BDI II)
Timepoint [10] 7033 0
Visit Randomisation, Visit End Titration and Visit Assessment 6.
Secondary outcome [11] 242296 0
Mean reduction in pain intensity using the daily Numerical Rating Scale (NRS).
Timepoint [11] 242296 0
Visit Screening then daily up to Visit Assessment 6.

Eligibility
Key inclusion criteria
1. Patients of either gender aged 18 years or older.
2. History of ongoing pain due to PHN of at least three months duration following initial Acute Herpes Zoster (AHZ) infection and rash healing, with pain intensity at screening visit of at least moderate intensity (NRS = 4/10).

3. Willingness to discontinue any current weak opioid analgesics (codeine-containing, propoxyphene-containing or tramadol) and any topical PHN therapies.

4. Patients receiving non-opioid adjuvant analgesic medications (e.g. antidepressants, AEDs, mexiletine, clonidine) or NSAIDs / COX-2 inhibitors must have a documented history of stable use over the previous three weeks with agreement to continue at a stable dosage for the duration of the trial.

5. Patients willing and able to participate in all aspects of the study, including initial medication weaning and cessation (if applicable), use of medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts and patient diary, and compliance with protocol requirements as evidenced by providing written, informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Previous or current treatment with Buprenorphine Transdermal System (BTDS)for Post Herpetic Neuralgia (PHN).

2. Patients treated, either currently or previously for PHN, with any strong opioid analgesic. (e.g. oxycodone, morphine, hydromorphone, fentanyl, methadone).

3. Patients currently treated with any strong opioid analgesic for any indication (e.g. oxycodone, morphine, hydromorphone, fentanyl, methadone).

4. Patients who have undergone somatic or sympathetic nerve blockade or other interventional therapies for PHN within the previous two months, or who have previously undergone neurolytic / neurosurgical treatment for PHN.

5. Patients treated with any analgesics within the last 12-hours prior to the randomisation visit, other than a] NSAIDs or adjuvant analgesic medications with dose/frequency stable for at least 3-weeks prior to study entry and continued at the stable dose/frequency for the duration of the study, and b] aspirin for cardiovascular or cerebrovascular indications up to a maximum dose of 300mg daily.

6. Hypersensitivity to opioid analgesics, transdermal delivery systems or patch adhesive such that involvement in the study would be inadvisable in the opinion of the Investigator.

7. Known intolerance to buprenorphine (e.g. Norspan, Temgesic) and/or paracetamol.

8. Use of a Monoamine Oxidase Inhibitor (MAOI) within the last 14 days.

9. History of alcohol abuse or prescription or non-prescription drug abuse or addiction.

10. Significant pain of alternative aetiology.

11. Evidence of clinically significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, neurological or psychiatric disease, as determined by medical history, clinical laboratory tests, Electrocardiogram (ECG) results, and physical examination, that would place the patient at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results.

12. Patients with clinically unstable cardiac disease including: unstable atrial fibrillation, symptomatic bradycardia, unstable cardiac failure, or active myocardial ischaemia.

13. Patients with a history of long QT syndrome (or an immediate family member with this condition), or with QT prolongation on initial screening ECGs (QTc = 480 milliseconds), or who have hypokalaemia on initial laboratory testing (as defined by testing laboratory), or patients currently receiving Class Ia antiarrhythmic medications (eg quinidine, mexiletine, procainamide) or Class III antiarrhythmic medications (e.g. sotalol, amiodarone).

14. Patients with evidence of significant impairment of liver function (values = 3 times upper limit of normal for Aspartate transaminase (AST) or Alanine transaminase (ALT)), or in the Investigator’s opinion, liver function impairment to the extent that the patient should not participate in the study.

15. Patients receiving hypnotics or other central nervous system (CNS) depressants that, in the Investigator’s opinion, may pose a clinically significant risk of additional CNS depression with opioid study medication.

16. Patients who have been administered a study drug in a clinical study within within 30 days of study entry (defined as the start of the Screening Period).

17.PRN use of Benzodiazepines other than a nocturnal dose for sleep.

18. Patients likely to receive any additional treatment which may interfere with study design or interfere with involvement in study.

19. Patients who have an ongoing requirement for treatment with direct external heat sources which may potentially interfere with the BTDS.

20. Patients with a dermatological disorder at any relevant patch application site that precludes proper placement and/or rotation of the patch, or with a history of eczema or cutaneous atrophy.

21. Patients unwilling or unable to give informed consent.

22. Pregnant or lactating women or women of childbearing potential not using effective contraception.

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)
Centralised Randomisation system using an Interactive Web Response System
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation schedule generated by computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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] 3354 0
Commercial sector/Industry
Name [1] 3354 0
Mundipharma Pty Limited
Address [1] 3354 0
50 Bridge St
Sydney 2000
Country [1] 3354 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Mundipharma Pty Limited
Address
50 Bridge St
Sydney 2000
Country
Australia
Secondary sponsor category [1] 3002 0
None
Name [1] 3002 0
Address [1] 3002 0
Country [1] 3002 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5379 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 5379 0
First Floor, 71 Anzac Highway, Ashford, South Australia, 5035
Ethics committee country [1] 5379 0
Australia
Date submitted for ethics approval [1] 5379 0
Approval date [1] 5379 0
07/02/2008
Ethics approval number [1] 5379 0

Summary
Brief summary
The aim of this study is to evaluate the clinical efficacy and safety of Norspan (registered trademark)(Buprenorphine Transdermal Delivery System, BTDS) in reducing neuropathic pain in patients with Postherpetic Neuralglia (PHN) compared with those on a placebo patch.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28566 0
Prof Michael Cousins
Address 28566 0
Professor & Director
Pain Management Research Institute
Level 5, Royal North Shore Hospital
St Leonards, NSW 2065
Country 28566 0
Australia
Phone 28566 0
N/A
Fax 28566 0
Email 28566 0
mcousins@nsccahs.health.nsw.gov.au
Contact person for public queries
Name 11723 0
Dr Christine Smith
Address 11723 0
50 Bridge St Sydney 2000
Country 11723 0
Australia
Phone 11723 0
+612 9231 7200
Fax 11723 0
Email 11723 0
christine.smith@mundipharma.com.au
Contact person for scientific queries
Name 2651 0
Dr Christine Smith
Address 2651 0
50 Bridge St Sydney 2000
Country 2651 0
Australia
Phone 2651 0
+612 9231 7200
Fax 2651 0
Email 2651 0
christine.smith@mundipharma.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary