Trials / Unknown
UnknownNCT03007160
A Study on the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence
A Randomized, Blank Controlled, Multicenter Clinical Trial of the Effection of Potassium Citrate Extended-release Tablets on Urolithiasis Formation or Recurrence
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 2,001 (estimated)
- Sponsor
- Dawnrays Pharmaceutical (Holdings) Limited · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence.
Detailed description
This study takes "Rate of stone recurrence" as primary outcome measure, by random, blank control, and multicenter clinical trial design method, assess the efficacy and safety of potassium citrate extended-release tablets on Urolithiasis formation or recurrence, provide evidence for drug re-registration, and observe its efficacy on Urinary calculi such as renal tubular acidosis with calcium stone, and uric acid stones with or without calcium stone, urinary tract stone of effectiveness.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Potassium Citrate Extended-release Tablets | Daily 3.24g, Po ,Tid, each 1.08g/tablets |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2020-09-01
- Completion
- 2020-09-01
- First posted
- 2017-01-02
- Last updated
- 2018-02-01
Locations
6 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03007160. Inclusion in this directory is not an endorsement.