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NCT00132392 · ClinicalTrials.gov registry record · Phase 2
ALGRX 4975 After Total Knee Replacement
A Phase 2 study, sponsored by AlgoRx Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00132392 is a Phase 2 study that has completed, run by AlgoRx Pharmaceuticals. The registered enrollment target is 40 participants.
The verdict
NCT00132392, a Phase 2 study, has completed, sponsored by AlgoRx Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
ALGRX 4975 or placebo will be dripped onto the cut muscles and soft tissues before the end of surgery for total replacement of the knee. Each subject will undergo a screening visit; a hospitalization, during which total replacement of the knee will be performed; and follow-up visits at 2, 6, and 12 weeks after surgery. In addition, once discharged, subjects will be contacted by telephone daily up to Day 14. Subjects will complete pain and medication diaries during the first 2 weeks following surgery and will return these diaries at the 2 week visit. Starting on the afternoon of Day 0 (the day of surgery), pain on active range of motion (ROM) of the operated knee will be measured each morning at 8 AM ± 2 hours and each afternoon at 3 PM ± 3 hours. In addition, if the subject ambulates, pain with ambulation will be measured during the first ambulation in the morning and during the first ambulation after noon. Subjects will complete the Brief Pain Inventory - Short Form (BPI-SF) preoperatively, and at the 2, 6, and 12 week visits. Subjects will be questioned regarding the use of assistive devices (cane, walker, wheelchair, bedside commode, or other assistive devices) at screening, at discharge, and at the 2, 6, and 12 week visits. The active ROM on flexion of the knee, measured using a goniometer, will be recorded at screening and at the 2 week visit. Sensory mapping of the knee will be performed at screening and at the 12 week visit.
Interventions
- DRUG ALGRX 4975
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2005-07 |
| Est. Completion | 2005-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00132392
The ClinicalTrials.gov registry entry for NCT00132392 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AlgoRx Pharmaceuticals, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ALGRX 4975 is the first listed.
NCT00132392 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00132392 about?
NCT00132392 is a clinical study titled "ALGRX 4975 After Total Knee Replacement". ALGRX 4975 or placebo will be dripped onto the cut muscles and soft tissues before the end of surgery for total replacement of the knee. Each subject will undergo a screening visit; a hospitalization, during which total replacement of the knee will be performed; and follow-up visits at 2, 6, and 12...
What is the current status of trial NCT00132392?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2005-07. Estimated completion is 2005-12.
What interventions are being tested in trial NCT00132392?
The interventions under investigation include: ALGRX 4975 (DRUG).
Who is sponsoring clinical trial NCT00132392?
This trial is sponsored by AlgoRx Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
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