Phase 2
Completed N=151
Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940
Source: ClinicalTrials.gov NCT00659490 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Pain Area Under the Curve 0-8h (AUC0-8h) — 355; 356; 129 mm*h
Summary
The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1940 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 Pain Area Under the Curve 0-8h (AUC0-8h) |
355; 356; 129 | — |
| SECONDARY Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h) |
145; 143; 54 | — |
| SECONDARY Maximum Pain Based on VAS Scale |
66; 65; 33 | — |
| SECONDARY Mean Pain Based on a VAS Scale |
31; 29; 13 | — |
| SECONDARY Pain at Jaw Movement AUC0-8h |
342; 337; 135 | — |
| SECONDARY Pain at Jaw Movement AUC0-4h |
142; 138; 53 | — |
| SECONDARY Maximum Pain at Jaw Movement |
63; 63; 33 | — |
| SECONDARY Mean Pain at Jaw Movement |
32; 28; 14 | — |
| SECONDARY Pain at Rescue Medication |
73; 70; 47 | — |
| SECONDARY Pain at Jaw Movement at Time of First Rescue Medication |
67; 65; 53 | — |
| SECONDARY Time to First Intake of Rescue Medication. |
3.8; 3.7; 4.7 | — |
| SECONDARY Number of Patients Requesting Rescue Medication |
37; 43; 7 | — |
| SECONDARY Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated |
22; 26; 28 | — |
| SECONDARY Maximum Deterioration in VAMS High |
30; 12; 20 | — |
| SECONDARY Maximum Deterioration in VAMS Anxious |
20; 15; 13 | — |
| SECONDARY Maximum Deterioration in VAMS Sedated |
33; 21; 24 | — |
| SECONDARY Maximum Deterioration in VAMS Down |
20; 25; 24 | — |
| SECONDARY Time to Max Deterioration in VAMS Stimulated |
143; 163; 213 | — |
| SECONDARY Time to Max Deterioration in VAMS High |
115; 191; 193 | — |
| SECONDARY Time to Max Deterioration in VAMS Anxious |
126; 167; 212 | — |
| SECONDARY Time to Max Deterioration in VAMS Sedated |
190; 221; 227 | — |
| SECONDARY Time to Max Deterioration in VAMS Down |
227; 262; 349 | — |
Eligibility Criteria
Inclusion Criteria
- Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar.
- Provision of signed informed consent.
- Healthy males or non-fertile females.
Exclusion Criteria
- History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
- History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorder, 4th edition.
Data sourced from ClinicalTrials.gov (NCT00659490). 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.