Trials / Completed
CompletedNCT04846673
Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy
Efficacy and Safety of Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy: a Randomized, Parallel, Open-label, Multicenter, Phase IV Clinical Trial (OPTIMUM Trial)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 151 (actual)
- Sponsor
- Yuhan Corporation · Industry
- Sex
- All
- Age
- 19 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is a randomized, parallel, open-label, multicenter, phase IV clinical trial to assess the efficacy and safety of pregabalin and alpha-lipoic acid combination compared with each monotherapy in patients with diabetic peripheral neuropathy for 12 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pregabalin 150mg + Alpha-lipoic acid 480mg | Pregabalin qd + alpha-lipoic acid qd |
| DRUG | Pregabalin 150mg | pregabalin qd |
| DRUG | Alpha-Lipoic Acid 480mg | alpha-lipoic acid qd |
Timeline
- Start date
- 2021-05-14
- Primary completion
- 2022-11-30
- Completion
- 2022-11-30
- First posted
- 2021-04-15
- Last updated
- 2025-04-03
Locations
14 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT04846673. Inclusion in this directory is not an endorsement.