Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07785544 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Efficacy and Safety of Low-Dose Duloxetine Plus Alpha-Lipoic Acid Versus Standard-Dose Duloxetine in Painful Diabetic Peripheral Neuropathy

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Bangladesh Medical University

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified
    • Secondary endpoints revised (6)
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will evaluate the efficacy and safety of low-dose duloxetine combined with alpha-lipoic acid compared with standard-dose duloxetine in adults with painful diabetic peripheral neuropathy. In this assessor-blinded, randomized, parallel-arm, non-inferiority trial, participants will be assigned in a 1:1 ratio to receive either duloxetine 30 mg once daily plus alpha-lipoic acid 600 mg once daily or duloxetine 60 mg once daily. The primary outcome will be the change in pain intensity measured by the Numerical Rating Scale from baseline to Week 9. Secondary outcomes will include changes in pain intensity at Week 5, Patient Global Impression of Change at Weeks 5 and 9, the proportion of participants achieving at least a 30% reduction in pain intensity, adverse effects, treatment tolerability and treatment compliance.
Trial Details
NCT Number NCT07785544
Lead Sponsor Bangladesh Medical University
Conditions
(from sponsor)		 Painful Diabetic Peripheral Neuropathy
Enrollment 170 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov