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

IBSA

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: Diclofenac sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01706588

12UK/DCsc04

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 5 patient groups, including a placebo group

Diclofenac sodium 5 mg/mL

Experimental group

Treatment:

Drug: Diclofenac sodium

Diclofenac sodium 12.5 mg/mL

Experimental group

Treatment:

Drug: Diclofenac sodium

Diclofenac sodium 25 mg/mL

Experimental group

Treatment:

Drug: Diclofenac sodium

Diclofenac sodium 50 mg/mL

Experimental group

Treatment:

Drug: Diclofenac sodium

Placebo 1 mL

Placebo Comparator group

Treatment:

Drug: Diclofenac sodium