Injectable Diclofenac for the Prevention of Post-operative Dental Pain

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

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.

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) of the Pain Scores.	Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery	Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

Secondary Outcome Measures

Name	Time	Method
Postsurgical Extra-oral Swelling	measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
Trismus	measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
Time to First Use of Rescue Medication.	measured from end of surgery up to 1 week postsurgery
Peak Pain Intensity	measured from end of surgery up to 12 hours postsurgery
Amount of Rescue Medication	consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery
Rescue Medication Consumption	consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery
Patient and Investigator Global Evaluation of the Effectiveness of Treatment	at 6 hour postsurgery and on Day 3
Time to Onset of Pain	measured from end of surgery up to 12 hours postsurgery
Vital Signs	presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.
Number of Patients With Adverse Events	from signature of the informed consent to 1 week postsurgery
Recurrent Bleeding	every hour up to 6 hour postsurgery
Wound Healing	at 6 hour postsurgery, and on day 3 and 1 week postsurgery