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NCT01919164 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee
A Phase 2 study, sponsored by EMD Serono Research & Development Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 549
- Enrollment target
NCT01919164 is a Phase 2 study that has completed, run by EMD Serono Research & Development Institute. The registered enrollment target is 549 participants.
The verdict
NCT01919164, a Phase 2 study, has completed, sponsored by EMD Serono Research & Development Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 549 participants
- Enrollment target
Study Summary
This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial of Sprifermin administered intra-articularly in participants with primary osteoarthritis of the knee and Kellgren-Lawrence Grade 2 or 3. The trial was intended to investigate the efficacy and safety of different intra articular dosages of Sprifermin in these individuals.
Interventions
- DRUG Placebo
- DRUG Sprifermin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 549 participants |
| Start Date | 2013-07-29 |
| Est. Completion | 2019-05-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01919164
The ClinicalTrials.gov registry entry for NCT01919164 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 549 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono Research & Development Institute, which has 81 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01919164 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01919164 about?
NCT01919164 is a clinical study titled "A Study to Investigate the Safety and Effectiveness of Different Doses of Sprifermin in Participants With Osteoarthritis of the Knee". This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 2 trial of Sprifermin administered intra-articularly in participants with primary osteoarthritis of the knee and Kellgren-Lawrence Grade 2 or 3. The trial was intended to investigate the efficacy and safety of...
What is the current status of trial NCT01919164?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 549 participants. The study started on 2013-07-29. Estimated completion is 2019-05-07.
What interventions are being tested in trial NCT01919164?
The interventions under investigation include: Placebo (DRUG), Sprifermin (DRUG).
Who is sponsoring clinical trial NCT01919164?
This trial is sponsored by EMD Serono Research & Development Institute, which has 81 total clinical trials registered on ClinicalTrials.gov.
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