Injectable Diclofenac for the Prevention of Post-operative Dental Pain
Information source: IBSA Institut Biochimique SA
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Diclofenac sodium (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: IBSA Institut Biochimique SA Official(s) and/or principal investigator(s): Thomas Dietrich, MD, Principal Investigator, Affiliation: The School of Dentistry, University of Birmingham
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.
Clinical Details
Official title: Preliminary Evaluation of the Efficacy and Local Tolerability of Injectable Diclofenac at 5, 12.5, 25 and 50 mg/mL, Administered Locally Prior to Surgery for the Prevention of Post-operative Pain After Third Molar Surgery
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Area Under the Curve (AUC) of the Pain Scores.
Secondary outcome: Postsurgical Extra-oral SwellingTrismus Peak Pain Intensity Time to First Use of Rescue Medication. Amount of Rescue Medication Rescue Medication Consumption Patient and Investigator Global Evaluation of the Effectiveness of Treatment Time to Onset of Pain Wound Healing Recurrent Bleeding Vital Signs Number of Patients With Adverse Events
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Out-patients of either gender.
2. Patients aged ≥ 18 to ≤ 65 years old.
3. Subjects able and willing to give their written consent prior to inclusion in the
study.
4. 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.
5. 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.
6. Patients undergoing surgical extraction of a single, fully or partially impacted
mandibular 3rd molar requiring bone removal.
Exclusion Criteria:
General
1. Patients refusing to give written informed consent.
2. Patients not able to understand the purposes of the study or not willing to return
for the control visits.
3. Patients with major psychiatric disorders that, in the investigator's opinion, could
compromise study participation.
4. Patients enrolled in any clinical trial in the previous 3 months.
5. 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.
6. Pregnant or breast-feeding women.
7. Alcohol or drug abuse in the previous 12 months.
8. Clinically significant or unstable concomitant disease whose sequelae might interfere
with the study evaluation parameters.
Locations and Contacts
The School of Dentistry University of Birmingham, Birmingham B4 6NN, United Kingdom
Additional Information
Starting date: January 2013
Last updated: August 28, 2014
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