Phase 2
N=75
Injectable Diclofenac for the Prevention of Post-operative Dental Pain
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01706588 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Area Under the Curve (AUC) of the Pain Scores. — 6843; 8832; 9998; 7290 mm*minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Diclofenac sodium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- IBSA Institut Biochimique SA
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) of the Pain Scores. |
6843; 8832; 9998; 7290; 15539 | — |
| SECONDARY Postsurgical Extra-oral Swelling |
— | — |
| SECONDARY Trismus |
— | — |
| SECONDARY Peak Pain Intensity |
— | — |
| SECONDARY Time to First Use of Rescue Medication. |
— | — |
| SECONDARY Amount of Rescue Medication |
— | — |
| SECONDARY Rescue Medication Consumption |
— | — |
| SECONDARY Patient and Investigator Global Evaluation of the Effectiveness of Treatment |
— | — |
| SECONDARY Time to Onset of Pain |
— | — |
| SECONDARY Wound Healing |
— | — |
| SECONDARY Recurrent Bleeding |
— | — |
| SECONDARY Vital Signs |
— | — |
| SECONDARY Number of Patients With Adverse Events |
— | — |
Summary
This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in approximately 75 patients undergoing surgical removal of an impacted lower third molar.
Eligibility Criteria
Inclusion Criteria
- Out-patients of either gender.
- Patients aged ≥ 18 to ≤ 65 years old.
- Subjects able and willing to give their written consent prior to inclusion in the study.
- Female subjects of childbearing potential must (1) have a negative urine pregnancy test at the inclusion visit, (2) be using an appropriate method of contraception according to the definition of Note of ICH M3 Guideline (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner), and (3) be willing to continue using the contraceptive method throughout the entire study period.
- Subjects must (1) be able to comprehend the full nature and purpose of the study, including possible risks and side effects, (2) fully co-operate with the Investigator, (3) comply with the requirements of the entire study.
- Patients undergoing surgical extraction of a single, fully or partially impacted mandibular 3rd molar requiring bone removal.
Exclusion Criteria
General
- Patients refusing to give written informed consent.
- Patients not able to understand the purposes of the study or not willing to return for the control visits.
- Patients with major psychiatric disorders that, in the investigator's opinion, could compromise study participation.
- Patients enrolled in any clinical trial in the previous 3 months.
- Employees of the study centre with direct involvement in the proposed study or other studies under the direction of the main investigator or study centre, as well as family members of the employees or investigator.
- Pregnant or breast-feeding women.
- Alcohol or drug abuse in the previous 12 months.
- Clinically significant or unstable concomitant disease whose sequelae might interfere with the study evaluation parameters.
Data sourced from ClinicalTrials.gov (NCT01706588). 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.