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NCT04814719 · ClinicalTrials.gov registry record
Treatment and Duration Effect of Pentosan Polysulfate Sodium (PPS) in Participants With Knee Osteoarthritis Pain
A clinical trial, sponsored by Paradigm Biopharmaceuticals.
- Completed
- Registry status
- 133
- Enrollment target
NCT04814719: Completed study, sponsored by Paradigm Biopharmaceuticals.
NCT04814719 is a clinical trial that has completed, run by Paradigm Biopharmaceuticals. The registered enrollment target is 133 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04814719 has completed, sponsored by Paradigm Biopharmaceuticals.
- COMPLETED
- Registry status
- 133 participants
- Enrollment target
Study Summary
The purpose of this study is to measure the duration of treatment effect with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adult participants with knee osteoarthritis (OA) pain. The study duration will be up to 34 weeks. Participants who completed pDay 162 of Study PARA\_OA\_002 (i.e. did not discontinue/withdraw prematurely from the parent study) will be invited to participate.
Primary Outcome
Time from initial response in the parent study (PARA\_OA\_002) to loss of OMERACT-OARSI (Outcomes Measures in Rheumatology - Osteoarthritis Research Society International) response.
Interventions
- DRUG Placebo (Sodium Chloride Injection, 0.9%)
- DRUG Pentosan Polysulphate Sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2023-06-24 |
| Est. Completion | 2024-12-24 |
What the finished NCT04814719 record still lists
NCT04814719 is an observational study that tracks outcomes without assigning an intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Placebo (Sodium Chloride Injection, 0.9%) is the first listed.
NCT04814719 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04814719 about?
NCT04814719 is a clinical study titled "Treatment and Duration Effect of Pentosan Polysulfate Sodium (PPS) in Participants With Knee Osteoarthritis Pain". The purpose of this study is to measure the duration of treatment effect with subcutaneous injections of pentosan polysulfate sodium (PPS) compared with placebo in adult participants with knee osteoarthritis (OA) pain. The study duration will be up to 34 weeks. Participants who completed pDay 162 o...
What is the current status of trial NCT04814719?
This trial is currently completed. The enrollment target is 133 participants. The study started on 2023-06-24. Estimated completion is 2024-12-24.
What interventions are being tested in trial NCT04814719?
The interventions under investigation include: Placebo (Sodium Chloride Injection, 0.9%) (DRUG), Pentosan Polysulphate Sodium (DRUG).
Who is sponsoring clinical trial NCT04814719?
This trial is sponsored by Paradigm Biopharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov.
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