Injectable Diclofenac for the Prevention of Post-operative Dental Pain

Pain Clinical Trial

— DP4  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706588
• Other study ID #: 12UK/DCsc04
• Status: Completed
• Phase: Phase 2
• First received: October 1, 2012
• Last updated: August 28, 2014
• Start date: January 2013
• Est. completion date: May 2013

Study information

• Verified date: August 2014
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.

Locations

Country	Name	City	State
United Kingdom	The School of Dentistry University of Birmingham	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Postsurgical Extra-oral Swelling		measured at 6 hours postsurgery, at day 3 and 1 week postsurgery	No
Secondary	Trismus		measured at 6 hours postsurgery, at day 3 and 1 week postsurgery	No
Secondary	Peak Pain Intensity		measured from end of surgery up to 12 hours postsurgery	No
Secondary	Time to First Use of Rescue Medication.		measured from end of surgery up to 1 week postsurgery	No
Secondary	Amount of Rescue Medication		consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery	No
Secondary	Rescue Medication Consumption		consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery	No
Secondary	Patient and Investigator Global Evaluation of the Effectiveness of Treatment		at 6 hour postsurgery and on Day 3	No
Secondary	Time to Onset of Pain		measured from end of surgery up to 12 hours postsurgery	No
Secondary	Wound Healing		at 6 hour postsurgery, and on day 3 and 1 week postsurgery	Yes
Secondary	Recurrent Bleeding		every hour up to 6 hour postsurgery	Yes
Secondary	Vital Signs		presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.	Yes
Secondary	Number of Patients With Adverse Events		from signature of the informed consent to 1 week postsurgery	Yes