Diabtes and its complications, painful neuropathy
Conditions
Interventions
Trade Name: Lyrica
Product Name: Lyrica
Product Code: pregabalin
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: PREGABALIN
CAS Number: 148553508
Current Sponsor code: Pregabalin
Other descrip
Sponsors
University of Birmingham
Birmingham Heartlands Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type 1 or type 2 diabetes as defined by the World Health Organization Classification. 2. Duration of diabetes of at least 5 years. 3. The HbA1c should be =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Nursing mothers, pregnant women (excluded by a negative pregnancy test). 2. Patients with a history of drug or alcohol dependence in the last 5 years 3. Patients with severe systemic disease other than diabetes which has as a recognized complication neuropathy or severe chronic pain 4. Patients with symptoms of neuropathic pain in the upper limbs alone 5. Significant changes in skin conditions in the areas to be tested which could alter sensation. 6. Patients currently taking medications that could affect symptoms of painful DN except acetominophen (up to 3g/d) or aspirin (up to 325 mg/d). 7. Patients experiencing an increase in pain after analgesic medication washout to levels which would, in the view of the PI, require prohibited analgesic therapy within a 6 wk period. 8. Patients whose creatinine clearance is less than 70 ml/min or have significant hepatic disease (AST, ALT, ?GT >2 times upper limit for normal). Patients with TSH outside normal limits 9. Patients with a history of previous kidney, pancreas or cardiac transplantation. 10. Serious or unstable medical or psychological state that may interfere with study participation. 11. Patients having taken other systemic investigational drugs (especially for neuropathy) or initiating a new or experimental insulin delivery device within 3 months of starting the study. 12.patients with a hypersensivity to pregabalin 13. Patients who refuse to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of pregabalin on cerebral pain processing and sensory perception thresholds in diabetic patients with Painful Diabetic Neuropathy.;Secondary Objective: To determine the effect of pregabalin on pain-related brain activity at rest and during noxious thermal stimulation using blood oxygen level-dependent (BOLD) contrast functional magnetic resonance imaging (fMRI) To determine the effects of pregabalin on cerebral evoked potential (EP) response at rest and during noxious thermal stimulation ;Primary end point(s): A 6 week placebo-controlled, cross-over clinical study will be conducted in patients with PDN. Subjects who are eligible for the study will be randomized to one of two treatment groups: Group 1: Pregabalin (75 mg bd) (Pfizer Pharmaceutical Company), or Group 2: matched oral placebos for 2 weeks, then undergo a 2 week washout period and then cross over to the alternative therapy for 2 weeks. Weekly Activities: Subjects will complete pain diaries and sleep interference scores on a weekly basis. All subjects will be reviewed at 2 weekly intervals when compliance will be reassessed. At two weekly visits, the following procedures will be performed: Assessment of compliance; blood pressure and pulse evaluation; evaluation of current medications; collection of study drug; recording of adverse symptoms/events. Collection of data from weekly pain diaries and sleep interference scores. SF-MMPQ will be completed at each visit. At the two and six weekly visits, the following additional procedures will be performed: BOLD-contrast fMRI and somatosensory psychophysics will be performed and cerebral EP responses to thermal noxious stimulation recorded. laser doppler ans skin biopsies will also be undertaken. Clinical and Global Impression of Change questionnaires will be completed. A blood draw will include glycaemic (glucose, HbA1c) measurements. The follow-up evaluation: All patients will be contacted 4 wk after the final | — |
Countries
United Kingdom
Outcome results
None listed