Injectable Diclofenac for the Prevention of Post-operative Dental Pain (DP4)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Diclofenac sodium

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom, B4 6NN
    • The School of Dentistry University of Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diclofenac sodium 5 mg/mL	Drug: Diclofenac sodium; One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.; Other Names: Diclofenac HPBCD
Experimental: Diclofenac sodium 12.5 mg/mL	Drug: Diclofenac sodium; One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.; Other Names: Diclofenac HPBCD
Experimental: Diclofenac sodium 25 mg/mL	Drug: Diclofenac sodium; One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.; Other Names: Diclofenac HPBCD
Experimental: Diclofenac sodium 50 mg/mL	Drug: Diclofenac sodium; One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.; Other Names: Diclofenac HPBCD
Placebo Comparator: Placebo 1 mL	Drug: Diclofenac sodium; One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.; Other Names: Diclofenac HPBCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUC) of the Pain Scores.	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).	Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Peak Pain Intensity	measured from end of surgery up to 12 hours postsurgery
Time to First Use of Rescue Medication.	measured from end of surgery up to 1 week 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
Wound Healing	at 6 hour postsurgery, and on day 3 and 1 week postsurgery
Recurrent Bleeding	every hour up to 6 hour 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

Collaborators and Investigators

• Sponsor: IBSA Institut Biochimique SA
• Investigators: Principal Investigator: Thomas Dietrich, MD, The School of Dentistry, University of Birmingham

Publications and helpful links

General Publications

• Gorecki P, Rainsford KD, Taneja P, Bulsara Y, Pearson D, Saund D, Ahmed B, Dietrich T. Submucosal Diclofenac for Acute Postoperative Pain in Third Molar Surgery: A Randomized, Controlled Clinical Trial. J Dent Res. 2018 Apr;97(4):381-387. doi: 10.1177/0022034517744207. Epub 2017 Dec 4.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: October 1, 2012
• First Submitted That Met QC Criteria: October 12, 2012
• First Posted (Estimate): October 15, 2012

Study Record Updates

• Last Update Posted (Estimate): September 5, 2014
• Last Update Submitted That Met QC Criteria: August 28, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: diclofenac, postsurgical pain, oral surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: 12UK/DCsc04