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NCT00988091 · ClinicalTrials.gov registry record · Phase 3
Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee
A Phase 3 study, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 596
- Enrollment target
NCT00988091: Completed Phase 3 study, sponsored by Ferring Pharmaceuticals.
NCT00988091 is a Phase 3 study that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 596 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00988091, a Phase 3 study, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 596 participants
- Enrollment target
Study Summary
Subjects with chronic osteoarthritis of the knee will be assigned to receive an injection of either 1.2% sodium hyaluronate or buffered saline to evaluate its effectiveness and safety for 26 weeks. After 26 weeks, subjects can elect to receive a second injection of 1.2% sodium hyaluronate and be followed for another 26 weeks.
Primary Outcome
The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were recorded on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. Change from baseline is calculated: week 26 VAS Pain Score - Baseline VAS Pain Score.
Interventions
- DEVICE 1.2% Sodium Hyaluronate
- DEVICE Buffered Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 596 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-04 |
| Phase | Phase 3 |
What the finished NCT00988091 record still lists
NCT00988091 is an interventional study that assigns participants to a tested intervention. The registered 596 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which 1.2% Sodium Hyaluronate is the first listed.
NCT00988091 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00988091 about?
NCT00988091 is a clinical study titled "Investigation of 1.2% Sodium Hyaluronate for Treatment of Painful Chronic Osteoarthritis of the Knee". Subjects with chronic osteoarthritis of the knee will be assigned to receive an injection of either 1.2% sodium hyaluronate or buffered saline to evaluate its effectiveness and safety for 26 weeks. After 26 weeks, subjects can elect to receive a second injection of 1.2% sodium hyaluronate and be fol...
What is the current status of trial NCT00988091?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 596 participants. The study started on 2009-09. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00988091?
The interventions under investigation include: 1.2% Sodium Hyaluronate (DEVICE), Buffered Saline (DEVICE).
Who is sponsoring clinical trial NCT00988091?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00988091's enrollment target sits among peer trials
596 640th of 2000 higher than 1,361 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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