Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia

Sponsor
Brainfarma Industria Química e Farmacêutica S/A
Study ID
NCT07712913
Phase
PHASE3
Status
Recruiting
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Conditions

  • Diabetic Neuropathy
  • Neuralgia, Postherpetic
  • Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Experimental: Pregabalin XR — DRUG
    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.
  • Comparator: Dorene Tabs — DRUG
    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 — DRUG
    Comparator placebo
  • experimental placebo — DRUG
    experimental placebo

Study Details

Extended-release Pregabalin for the Treatment of Neuropathic Pain in Patients With Diabetic Peripheral Neuropathy and Postherpetic Neuralgia

Key Dates

First listed
Jul 20, 2026
Start date
Jun 18, 2026
Status verified
Jul 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
348 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pregabalin XR: Extended-release pregabalin
    Pregabalin XR: will receive extended-release pregabalin tablets at an initial dose of 82.5 mg once daily (during the first week for titration). 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 may receive a placebo twice daily.
  • Active Comparator: Dorene Tabs: Immediate-release pregabalin
    Dorene Tabs: will receive immediate-release pregabalin tablets (Dorene Tabs) at a starting 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 comparison group will receive a placebo once daily.

Primary Outcome Measure

Difference in the mean pain intensity score 16 weeks after the start of treatment, compared to baseline [ Time Frame: 16 weeks ]

Central Contacts

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