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NCT05048563 · ClinicalTrials.gov registry record
Registry of Thiola EC Therapy
A clinical trial, sponsored by NYU Langone Health.
- Completed
- Registry status
- 25
- Enrollment target
NCT05048563: Completed study, sponsored by NYU Langone Health.
NCT05048563 is a clinical trial that has completed, run by NYU Langone Health. The registered enrollment target is 25 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05048563 has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- 25 participants
- Enrollment target
Study Summary
Thiola EC represents several modifications of Thiola that promise better, more efficacious therapy of cystinuria. First, pill size has changed from 100 mg to 300 mg, meaning that typical pill burden will be reduced from, on average, 10 pills per day to 3-5 pills per day. This change will be welcomed by patients whose fluid intake and administration of potassium citrate are daily impositions. Second, the preparation is now enteric-coated, formulated to offer delayed release of active tiopronin. Lastly, Thiola EC can be taken with food which is an improvement to the inconvenient dosing regimen of Thiola, which can only be taken one hour before, or two hours after meals. These changes may affect compliance and side effect profiles compared to those of Thiola. In combination with potassium citrate or other alkali preparations, adverse GI effects are relatively common in actively-treated patients with cystinuria. It is possible that GI side effects may be reduced by Thiola EC.
Primary Outcome
The WiSQoL questionnaire is designed to understand the quality of life of patients with a history of kidney stones. There are 7 main questions that each have sub-questions. The questions are answered on a scale from 1 (very true / always or almost always) to 5 (not at all true / not at all, never). The total range of questions is 28-140; the lower the score, the worse the quality of life.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2023-10-31 |
What the finished NCT05048563 record still lists
NCT05048563 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 25 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT05048563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05048563 about?
NCT05048563 is a clinical study titled "Registry of Thiola EC Therapy". Thiola EC represents several modifications of Thiola that promise better, more efficacious therapy of cystinuria. First, pill size has changed from 100 mg to 300 mg, meaning that typical pill burden will be reduced from, on average, 10 pills per day to 3-5 pills per day. This change will be welcomed...
What is the current status of trial NCT05048563?
This trial is currently completed. The enrollment target is 25 participants. The study started on 2021-03-02. Estimated completion is 2023-10-31.
Who is sponsoring clinical trial NCT05048563?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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