Neuropathic pain
Conditions
Interventions
Trade Name: Temgesic
Product Name: Temgesic
Product Code: Temgesic
Pharmaceutical Form: Injection*
INN or Proposed INN: Buprenorphine
CAS Number: 53152-21-9
Concentration unit: µg/ml microgram(s)/mill
Sponsors
Reckitt Benckiser (UK) Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed