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NCT05179460 · ClinicalTrials.gov registry record
A Study of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary Retinopathy
A clinical trial, sponsored by Janssen Research & Development.
- Completed
- Registry status
- 2
- Enrollment target
NCT05179460: Completed study, sponsored by Janssen Research & Development.
NCT05179460 is a clinical trial that has completed, run by Janssen Research & Development. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05179460 has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- 2 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate incidence and prevalence rates of the study endpoints (pigmentary maculopathy \[PM\]/ pigmentary retinopathy \[PR\]/Any, PM/PR/ pentosan polysulfate sodium \[PPS\], and PM/PR/Non-PPS) in relation to PPS exposure, and in participants with interstitial cystitis (IC) but not exposed to PPS; changes in visual acuity (VA) over time; participant treatment journey leading to PPS treatment, and potential risk factors associated with the occurrence of PM/PR/PPS.
Primary Outcome
Incidence rate is defined as number of incident cases per number of all participants at risk (that is, number of all participants exposed to pentosan polysulfate sodium \[PPS\]). Incidence rate is calculated by using formula: incidence rate (per 100 person-years)= number of incidence cases divided by number of person-years time at risk.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2021-10-26 |
| Est. Completion | 2022-05-20 |
What the finished NCT05179460 record still lists
NCT05179460 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT05179460 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05179460 about?
NCT05179460 is a clinical study titled "A Study of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary Retinopathy". The purpose of this study is to evaluate incidence and prevalence rates of the study endpoints (pigmentary maculopathy \[PM\]/ pigmentary retinopathy \[PR\]/Any, PM/PR/ pentosan polysulfate sodium \[PPS\], and PM/PR/Non-PPS) in relation to PPS exposure, and in participants with interstitial cystitis...
What is the current status of trial NCT05179460?
This trial is currently completed. The enrollment target is 2 participants. The study started on 2021-10-26. Estimated completion is 2022-05-20.
Who is sponsoring clinical trial NCT05179460?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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