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Eschscholtzia Californica vs Ibuprofen for Post-Surgical Dental Pain
NCT02187588Phase 2
Key facts
- Status
- Completed
- Start
- Feb 1998
- Primary completion
- May 1999
- Sponsor
- Boehringer Ingelheim
- Modality
- Botanical Extract
- Conditions
- postoperative pain
01
Overview
Phase 2, randomised, double-blind trial of California poppy extract in postoperative pain (4 arms), sponsored by Boehringer Ingelheim. Primary endpoint: Summed Pain Intensity Differences on Visual Analogue Scale up to 6 hours. Started Feb 1998; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Eschscholtzia Low Dose
Eschscholtzia Californica 500 mg
Eschscholtzia High Dose
Eschscholtzia Californica 1000 mg
Ibuprofen
Ibuprofen 200 mg
Placebo
Placebo
03
Who it enrols
Adult patients (18-61 years) undergoing third molar removal with moderate to severe post-surgical pain. Excludes pregnant/nursing women, patients with chronic pain, recent analgesic use, uncontrolled diabetes, or acute infections.
04
Endpoints
Primary
Summed Pain Intensity Differences on Visual Analogue Scale
Secondary
Pain Intensity Differences
Pain Intensity Difference at 2 Hours
Time Point for Maximum Pain Intensity Difference
Number of Patients with Pain Decrease of at Least 50%
Pain Relief on Verbal Rating Scale
Total Pain Relief on Verbal Rating Scale
Global Efficacy Assessment
Number of Patients Requiring Rescue Medication
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