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NCT00398866 · ClinicalTrials.gov registry record · Phase 3
A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb
A Phase 3 study, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
NCT00398866 is a Phase 3 study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 200 participants.
The verdict
NCT00398866, a Phase 3 study, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
Study Summary
Hyaluronan is a man-made preparation of a protein complex that occurs naturally in joints and that is often low in people with osteoarthritis. Although hyaluronan has been used in millions of people with knee osteoarthritis, it is not yet FDA approved for use in the thumb. The purpose of this study is to determine the safety and effectiveness of hyaluronan in relieving arthritis symptoms at the base of the thumb and to compare it to corticosteroids and local anesthetic. The principle hypothesis is that treating osteoarthritis at the carpometacarpophalangeal (CMC) joint with injectable hyaluronan will results in greater pain relief, higher patient satisfaction, and better functional outcomes than treating with placebo injections (local anesthetic) or with corticosteroid injections. Treating CMC osteoarthritis with corticosteroid injections will result in greater pain relief, higher patient satisfaction, and better functional outcomes than treating with placebo injections. Patients with worse pre-treatment function will have less improvement and worse post-treatment results after administration of corticosteroid or hyaluronan.
Interventions
- DRUG Synvisc (Hylan G-F20; hyaluronan injection)
- DRUG Bupivicaine (local anesthesia injection)
- DRUG Kenalog (triamcinolone; corticosteroid injection)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2006-08 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00398866
The ClinicalTrials.gov registry entry for NCT00398866 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Synvisc (Hylan G-F20; hyaluronan injection) is the first listed.
NCT00398866 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00398866 about?
NCT00398866 is a clinical study titled "A Study of Hyaluronan for the Treatment of Osteoarthritis in the Thumb". Hyaluronan is a man-made preparation of a protein complex that occurs naturally in joints and that is often low in people with osteoarthritis. Although hyaluronan has been used in millions of people with knee osteoarthritis, it is not yet FDA approved for use in the thumb. The purpose of this study ...
What is the current status of trial NCT00398866?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2006-08. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00398866?
The interventions under investigation include: Synvisc (Hylan G-F20; hyaluronan injection) (DRUG), Bupivicaine (local anesthesia injection) (DRUG), Kenalog (triamcinolone; corticosteroid injection) (DRUG).
Who is sponsoring clinical trial NCT00398866?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
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