Methods | Randomised, double blind, parallel group, partial enriched enrolment. 5-day titration (5 weeks in total) | |
Participants | Painful diabetic neuropathy for 1-5 years, and pain at least 40/100 mm. Mean age 60 years, 40% female, 95% white | |
Interventions | Pregabalin 75 mg daily, n = 77 Pregabalin 300 mg daily, n = 81 Pregabalin 600 mg daily, n = 82, Placebo daily, n = 97 |
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Outcomes | Proportion of patients with ≥ 50% decrease in mean pain score between endpoint and baseline, and other outcomes | |
Notes | Oxford quality score: R2, D2, W1 = 5/5 Pfizer sponsored |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Adequate sequence generation? | Yes | “random number table” |
Allocation concealment? | Yes | Remote administration |
Blinding? All outcomes |
Yes | double dummy technique |