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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 Swelling

Trismus

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

Page last updated: August 23, 2015

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