Phase 2
Completed N=103
Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386
Source: ClinicalTrials.gov NCT00672646 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcomePrimary: Sum of Pain Intensity Difference in Percent (SPID%) — 35.5; 171.8; -7.5 percentage of pain intensity change * h
Summary
The primary aim of this study is to investigate if AZD1386 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive naproxen as control.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Pain Intensity Difference in Percent (SPID%) |
35.5; 171.8; -7.5 | — |
| SECONDARY Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm) |
50; 48; 46.5; 33; 54; 45 | — |
| SECONDARY Time to First Perceptible Pain Relief |
0.3; 0.8; 1.3 | — |
| SECONDARY Time to First Meaningful Pain Relief |
8.0; 4.2; 8.0 | — |
| SECONDARY VAS Pain Intensity at Rescue Intake |
61.0; 69.0; 70.5 | — |
| SECONDARY VAS Pain on Jaw Movement at Rescue Intake |
65.0; 81.0; 73.5 | — |
Eligibility Criteria
Inclusion Criteria
- Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar.
- Provision of signed informed consent.
Exclusion Criteria
- History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
- Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
- A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives
- Patients with a body temperature >37.5°C at Visit 2, before start of surgical procedures
Data sourced from ClinicalTrials.gov (NCT00672646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.