Trials / Completed
CompletedNCT04094662
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled 14-week Study of DS-5565 in Chinese Patients With Diabetic Peripheral Neuropathic Pain
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 393 (actual)
- Sponsor
- Daiichi Sankyo Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Investigate the efficacy and safety of mirogabalin in Chinese participants with diabetic peripheral neuropathic pain in comparison to placebo.
Detailed description
The primary objective is to compare change from baseline in weekly Average Daily Pain Score (ADPS) at Week 14 in Chinese patients with Diabetic Peripheral Neuropathic Pain (DPNP) receiving mirogabalin versus placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mirogabalin | Mirogabalin tablets for oral administration |
| DRUG | Placebo | Matching placebo tablets for oral administration |
Timeline
- Start date
- 2019-09-18
- Primary completion
- 2022-01-17
- Completion
- 2022-01-24
- First posted
- 2019-09-19
- Last updated
- 2022-10-24
Locations
40 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04094662. Inclusion in this directory is not an endorsement.