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NCT00266786 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery
A Phase 3 study of Postoperative Pain, sponsored by Egalet.
- Completed
- Registry status
- Phase 3
- Development phase
- 321
- Enrollment target
- 6
- Study locations
NCT00266786 is a Phase 3 study of Postoperative Pain that has completed, run by Egalet. The registered enrollment target is 321 participants, above the 226-participant average among 63 other Postoperative Pain trials with a reported enrollment target (42% higher). The trial reports 6 study locations across 3 states.
The verdict
NCT00266786, a Phase 3 study of Postoperative Pain, has completed, sponsored by Egalet.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 321 participants
- Enrollment target
- 6
- Study locations
Study Summary
Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety. Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile. Patients will be randomized in a 2:1 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level (40 on a scale of 100) following surgery. After the first dose, subjects will receive study drug every 6 hours for 48 hours, and then as needed (up to 4 times a day) for a total of 5 days. If pain is not adequately relieved by the study drug, subjects will be given morphine sulfate or other standard analgesics. Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing. Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study, and will be given physical examinations, including nasal evaluations, before and during the clinical trial. A small amount of blood will be drawn for routine clinical laboratory testing.
Conditions Studied
Interventions
- DRUG Intranasal Placebo
- DRUG Intranasal Ketorolac Tromethamine
Study Locations (6)
California
- Methodist Hospital - Arcadia
- Glendale Adventist Medical Center - Glendale
- Clinical Management Services, Inc. - Pasadena
Texas
- Memorial Hermann Healthcare System - Houston
- Houston Perinatal Associates - Houston
Other
- Waikato Clinical Research - Hamilton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 321 participants |
| Start Date | 2005-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00266786
The ClinicalTrials.gov registry entry for NCT00266786 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 321 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 226-participant average among 63 other Postoperative Pain trials with a reported enrollment target (42% higher). The listed sponsor is Egalet, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Postoperative Pain appearing as the primary indexed condition, and to 2 interventions - of which Intranasal Placebo is the first listed.
NCT00266786 reports 6 study locations spanning 3 distinct geographic areas - top geographies include California, Texas, Other.
Frequently Asked Questions
What is clinical trial NCT00266786 about?
NCT00266786 is a clinical study titled "Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery". Ketorolac has been marketed for several years in other forms (tablet and injectable) for the short-term relief of pain. This study will test whether a new dosage form (nasal spray) containing ketorolac is effective at relieving the pain of major abdominal surgery, and will also assess product safety...
What is the current status of trial NCT00266786?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 321 participants. The study started on 2005-12.
What conditions does trial NCT00266786 study?
This clinical trial studies the following conditions: Postoperative Pain.
What interventions are being tested in trial NCT00266786?
The interventions under investigation include: Intranasal Placebo (DRUG), Intranasal Ketorolac Tromethamine (DRUG).
Who is sponsoring clinical trial NCT00266786?
This trial is sponsored by Egalet, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00266786 being conducted?
This trial has 6 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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