A randomised, double blind, crossover pilot study of intravenous buprenorphine versus intravenous buprenorphine/ naloxone in patients with chronic pain.
- Conditions
- Chronic pain
- Registration Number
- EUCTR2007-000329-22-GB
- Lead Sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
i) Written informed consent.
ii) Male or female patients aged 18 years or over.
iii) Patients with a recognised chronic pain condition greater than 3 months duration that has been diagnosed by a pain management specialist.
iv) Patients with moderate to severe chronic pain (defined as a minimum of 40 mm pain score on the 100mm pain visual analogue scale at screening and a minimum average daily pain score of 4 on an 11-point Likert scale (0, no pain; 10, worst pain ever experienced) during pre-treatment.
v) Adequate renal function (serum creatinine females <130 micro mol/l: males <150 micro mol/l).
vi) Liver enzymes (AST or ALT) less than twice the upper limit of normal. Alkaline phosphatase less than twice the upper limit of normal.
vii) Bilirubin within the normal range.
viii) Patients stabilised on regular doses of step II analgesics for at least 2 weeks prior to the pre-treatment period of the study. Regular doses of analgesia must be continued during the study period (except for the two treatment days).
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) yes
F.1.3.1 Number of subjects for this age range
i) Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, i.e. an oral contraceptive, an approved hormonal implant, an intrauterine device or condoms/diaphragm and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).
ii) Patients receiving sustained-release formulations of opioid analgesics or tramadol.
iii) Patients who have a history of experiencing intolerable opioid analgesic side effects.
iv) Patients who are receiving tricyclic antidepressants, anticonvulsants, membrane stabilisers or steroids for the pain if the doses have not been stable for the 2 weeks prior to the pre-treatment period of the study or if doses are likely to change during the study.
v) Patients who are receiving monoamine oxidase inhibitors, phenobarbital, carbamazepine, phenytoin, rifampicin, gestodene, troleandomycin, ketoconazole, norfluoxetine, ritonavir, indinavir or saquinavir.
vi) Abnormal serum electrolytes, which in the investigators opinion would exclude the patient from this study.
vii) Haemoglobin outside the normal limits and white blood cell count below the lower limit of normal or above 12 x 10^9/l.
viii) Patients who have anxiety or depression to such a degree that the investigators judge that participation in the study would be detrimental to their mental health.
ix) Patients who are unable to understand and complete assessment questionnaires in English and those unable to complete VAS scales.
x) Concurrent surgery, radiotherapy, chemotherapy or nerve blocks and those who have received this treatment 4 weeks prior to the study.
xi) Patients who are receiving, or have received buprenorphine based analgesia in the last 14 days.
xii) Patients who have been in another clinical study within the last 3 months.
xiii) Patients with a previous history of allergy or intolerance to buprenorphine, naloxone or paracetamol.
xiiii) Patients who have been previously randomised into the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method