Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia
A Phase III, Multicenter, Randomized, Double-blind, Double-dummy, Controlled, Parallel-group, Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of Extended-release Pregabalin Tablets Compared With Immediate-release Pregabalin Tablets, in the Relief of Neuropathic Pain in Participants With Diabetic Peripheral Neuropathy or Postherpetic Neuralgia.
Brainfarma Industria Química e Farmacêutica S/A
348 participants
Jun 18, 2026
INTERVENTIONAL
Conditions
Summary
Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
Pregabalin XR: extended-release tablet, with an initial dose of 82.5 mg once daily. The dose may be adjusted every 7 days during the first 4 weeks of treatment, up to a maximum of 660 mg once daily. In addition, the experimental group will receive a placebo twice daily.
Pregabalin immediate-release tablets, at an initial dose of 75 mg twice daily. The dose may be adjusted every 7 days during the first 4 weeks of treatment, up to a maximum of 300 mg twice daily. In addition, the comparator group will receive a placebo once daily.
Comparator placebo
experimental placebo
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT07712913