A preliminary single dose, three-way, double-blind, placebo-controlled crossover study of intravenous buprenorphine/naloxone in the treatment of neuropathic pain of diabetic neuropathy origin. - Buprenorphine/naloxone in neuropathic pai
- Conditions
- europathic pain
- Registration Number
- EUCTR2005-001356-20-GB
- Lead Sponsor
- Reckitt Benckiser (UK) Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
a) Subjects who are able to give voluntary, written informed consent to participate in the study and from whom consent has been obtained.
b) Subjects, aged over 18 years, without significant cognitive impairment, with peripheral neuropathy associated with diabetes mellitus (type 1 or 2).
c) Subjects with moderate or severe pain at screening on a 5-point Likert scale (0 – no pain; 1 – mild pain; 2 – moderate pain; 3 – severe pain; 4 – excruciating pain).
d) Subjects who are experiencing pain of at least 6 months duration.
e) Subjects who display at least one of the following symptoms of neuropathic pain – paraesthesia, dysaesthesia, hyperalgesia, allodynia.
f) Subjects who display signs of reduced sensation or tendon reflexes not attributable to any other cause.
g) Subjects with stable glycaemic control (HbA1c < 11%).
h) Subjects with normal hepatic and renal function.
i) Subject’s pre-study laboratory screen, which includes but is not limited to haematology (FBC, ESR), urinalysis, immunology (CRP), U&E, IFT and Glucose are normal or not considered clinically significant and there is no evidence of illicit drug use.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
a) Females with confirmed pregnancy (a negative pregnancy test will be required when entering the study and at each visit for women on child bearing potential).
b) Subjects with any contra-indications to opioids, specifically buprenorphine eg known to be allergic to Temgesic or hypersensitive to any of the constituents or suffering from respiratory depression.
c) Subjects with any contra-indications to opioid antagonists, specifically naloxone eg hypersensitivity, renal or hepatic disease.
d) Subjects with less than 5 half lives wash out from opioid use. Patients on long acting preparations (eg MST continus, Morcap SR etc) should be switched to a short acting alternative and then have this stopped.
e) Subjects with neuropathic or severe pain of any other cause including cancer.
f) Subjects with significant other co-morbidity (e.g. significant neurological or psychiatric disorders unrelated to neuropathic pain and that could interfere with pain assessment).
g) Subjects who have received in the previous 2 weeks any of the following drugs whose magnitude of an inducing or inhibitory effect on buprenorphine is unknown : gestodene, troleandomycin, ketonazole, norfluoxetine, ritonavir, indinavir, saquinavir, phenobarbital, carbamazepine, phenytoin and rifampicin.
h) Subjects with clinically significant renal or hepatic disease.
i) Subjects with routine biochemical abnormalities that are deemed to be clinically significant.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to confirm that the pain relieving effects seen with buprenorphine / naloxone in healthy volunteers are also seen in diabetic patients suffering from neuropathic pain.;Secondary Objective: The secondary objective of this study is to determine how well two different doses of buprenorphine / naloxone work in relieving pain and how well they are tolerated.;Primary end point(s): No primary end point as preliminary study
- Secondary Outcome Measures
Name Time Method