Trial registered on ANZCTR


Trial ID
ACTRN12609000647235
Ethics application status
Approved
Date submitted
29/07/2009
Date registered
30/07/2009
Date last updated
15/08/2013
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' Buprenorphine transdermal system [BTDS]) And Placebo In Patients With Diabetic Peripheral Neuropathic Pain.
Scientific title
A Multicentre, Randomised, Double-Blind, Parallel Group Comparison Of The Efficacy And Safety Of Transdermal Buprenorphine (Norspan'registered trade mark' Buprenorphine transdermal system [BTDS]) And Placebo In Patients With Diabetic Peripheral Neuropathic Pain.
Secondary ID [1] 280453 0
BUP3029
Universal Trial Number (UTN)
Trial acronym
ASSET DPNP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Peripheral Neuropathic Pain 237352 0
Condition category
Condition code
Neurological 239674 239674 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, titration at the physician's discretion evaluated at patient visits.
Patch is worn continuously for 7 days.
Duration of treatment: maximum of 16 weeks
Intervention code [1] 237012 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.
Patch is worn continuously for 7 days.
Duration of treatment: maximum of 16 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 240449 0
Proportion of subjects obtaining reductions in pain intensity from baseline to the end of the assessment phase of at least 30% based on the daily numerical rating scale (NRS) score for average pain intensity.
Timepoint [1] 240449 0
Visit Screening then daily up to the final assessment visit (i.e. final assessment visit is 12 weeks after randomisation).
Secondary outcome [1] 244961 0
Change from baseline in mean NRS score for average pain intensity to the end of the assessment phase
Timepoint [1] 244961 0
Visit Screening, Visit Wk12 (final assessment visit)
Secondary outcome [2] 244962 0
Change from baseline in mean NRS score for least pain intensity to each week of the study
Timepoint [2] 244962 0
All visits
Secondary outcome [3] 244963 0
Change from baseline in mean NRS score for worst pain intensity to each week of the study
Timepoint [3] 244963 0
All visits
Secondary outcome [4] 244964 0
Change from baseline in mean NRS score for night pain intensity to each week of the study.
Timepoint [4] 244964 0
All visits
Secondary outcome [5] 244965 0
Mean categorical scale score for pain relief to each week of the study.
Timepoint [5] 244965 0
All visits
Secondary outcome [6] 244966 0
Change from baseline in Neuropathic Pain Symptom Inventory (NPSI) scores for pain intensity, including total intensity score and subscores.
Timepoint [6] 244966 0
All visits
Secondary outcome [7] 244967 0
Proportion of subjects obtaining reductions in pain intensity from baseline to the end of the assessment phase of at least 50% based on the NRS
Timepoint [7] 244967 0
Visit Screening then daily up to the final assessment visit.
Secondary outcome [8] 244968 0
Median average daily dose of paracetamol rescue medication used during the trial, as reported in the patient daily diary.
Timepoint [8] 244968 0
Visit Screening then daily up to the final assessment visit.
Secondary outcome [9] 244969 0
differences in total medication usage between active an placebo treatment groups at Wk6 and final assessment visit (Wk12), as reported in the patient diary.
Timepoint [9] 244969 0
Visit Wk6, Visit Wk12
Secondary outcome [10] 244970 0
Change in Mean Daily Sleep Interference Scale (DSIS) to each week of the study.
Timepoint [10] 244970 0
All visits
Secondary outcome [11] 244972 0
Change in Short-Form McGill Pain Questionnaire (SF-MPQ) including total sore as well as sensory an affective pain dimension sub-scores, the Visual Analog Scale (VAS) Score rating pain over last 7 days and present pain intensity score.
Timepoint [11] 244972 0
Baseline, Visit Wk6, Visit Wk12
Secondary outcome [12] 244973 0
Change in interference by pain in daily activities as measured by the Breif Pain Inventory (BPI), as baseline, Wk6 and final assessment (Wk12)
Timepoint [12] 244973 0
Baseline, Visit Wk6, Visit Wk12
Secondary outcome [13] 244974 0
Change in affective state as measured by the Beck Depression Inventory (BDI-II) at baseline, Wk6 and final assessment (Wk12)
Timepoint [13] 244974 0
Baseline, Visit Wk6, Visit Wk12
Secondary outcome [14] 244975 0
change in affective state as measured by the Profile of Mood States (POMS), at baseline, Wk6 and final assessment visit (Wk12), which includes total score from the scale and an overall Mood disturbance scores for the key dimensions.
Timepoint [14] 244975 0
Baseline, Visit Wk6, Visit Wk12
Secondary outcome [15] 244976 0
Change in Health Related Quality of Life (QOL) as measured by the SF-36 at baseline, Wk6, Wk12.
Timepoint [15] 244976 0
Baseline, Visit Wk6, Visit Wk12
Secondary outcome [16] 244977 0
Patient Global Impression of Change at Wk6 and Final Assessment (Wk12)
Timepoint [16] 244977 0
Visit Wk6, Visit Wk12
Secondary outcome [17] 244978 0
Clinican global impression of change at Wk6 and final assessment visit.
Timepoint [17] 244978 0
Visit Wk6, Visit Wk12

Eligibility
Key inclusion criteria
Patients must have documented diagnosis of Type 1 or Type 2 diabetes mellitus for the last 6 months with stable glycaemic control for three months as assessed by the Investigator and a glycosylated haemoglobin (HbA1c) of <= 8.5% and without any major swings in blood glucose levels associated with frequent hypoglycaemia may enter the study.

Patients must have a history of diabetic peripheral neuropathic pain (DPNP) attributable to diabetic sensorimotor polyneuropathy on clinical grounds.

Patients must have a pain intensity of at least moderate intensity (NRS >= 4/10) at the screening visit (WkS).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient has other cause of neuropathy or lower extremity pain which may confound assessment of DPNP.

Patient has clinical evidence of active infection at the site of DPNP.

Patient has undergone prior neurolytic treatment (nerve destructive procedures by application of chemicals, heat or cold), intrathecal pump insertion, or spinal cord stimulation for DPNP or other lower limb symptomatology, or has had somatic or sympathetic nerve blocks within the last six months for DPNP or other lower limb symptomatology.

Patient has symptomatic Peripheral Vascular Disease (PVD).

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 a 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
Current
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 1918 0
New Zealand
State/province [1] 1918 0

Funding & Sponsors
Funding source category [1] 237403 0
Commercial sector/Industry
Name [1] 237403 0
Mundipharma Pty Limited
Address [1] 237403 0
50 Bridge Street
Sydney NSW 2000
Country [1] 237403 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] 236900 0
None
Name [1] 236900 0
Address [1] 236900 0
Country [1] 236900 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239534 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 239534 0
Bellberry Limited
229 Greenhill Road
Dulwich SA 5065
Ethics committee country [1] 239534 0
Australia
Date submitted for ethics approval [1] 239534 0
31/07/2009
Approval date [1] 239534 0
09/09/2009
Ethics approval number [1] 239534 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 Diabetic Peripheral Neuropathic Pain (DPNP) compared with those on a placebo patch.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes
N/A

Contacts
Principal investigator
Name 29963 0
Prof Dennis Yue
Address 29963 0
The Diabetes Centre
Royal Prince Alfred Hospital
Level 6, West Wing
Missenden Rd
Camperdown, NSW 2050
Country 29963 0
Australia
Phone 29963 0
+612 9515 5888
Fax 29963 0
N/A
Email 29963 0
dennis@email.cs.nsw.gov.au
Contact person for public queries
Name 13210 0
Dr Christine Smith
Address 13210 0
50 Bridge Street
Sydney NSW 2000
Country 13210 0
Australia
Phone 13210 0
+612 9231 7200
Fax 13210 0
Email 13210 0
christine.smith@mundipharma.com.au
Contact person for scientific queries
Name 4138 0
Dr Christine Smith
Address 4138 0
50 Bridge Street
Sydney NSW 2000
Country 4138 0
Australia
Phone 4138 0
+612 9231 7200
Fax 4138 0
Email 4138 0
christine.smith@mundipharma.com.au