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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.

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.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000647235
Acronym
ASSET DPNP
Enrollment
186
Registered
2009-07-30
Start date
2010-03-05
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Sponsors

Mundipharma Pty Limited
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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).

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).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026