Multicentre, randomised, double-blind (double-dummy), active comparator-controlled, phase III study of the efficacy and safety of a single s.c. Diclofenac HPBCD 75mg/1ml injection as compared to a single i.m. Voltarol® 75mg/3ml, in the treatment of acute moderate-to-severe post-surgical pain following dental surgery (impacted 3rd molar removal).

• Conditions: acute moderate-to-severe post-surgical pain from dental surgery (impacted 3rd molar extraction); MedDRA version: 9.1Level: HLTClassification code 10044049Term: Dental pain and sensation disorders

• Registration Number: EUCTR2009-011980-35-GB
• Lead Sponsor: IBSA Institut Biochimique SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

General
1.Out-patients of both genders.
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 have a negative urine pregnancy test at screening and inclusion visit (i.e. not status post hysterectomy or tubal ligation) must 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 of vasectomised partner) and must be willing to continue using it throughout the entire study period.
5.Subjects must be able to comprehend the full nature and purpose of the study, including possible risks and side effects, to co-operate with the Investigator, to comply with the requirements of the entire study and to return for the required examinations.

Trial specific
6.Patients undergoing surgical extraction of a single fully or partially impacted mandibular 3rd molar requiring bone removal.
7.Patients experiencing moderate to severe post-operative pain, defined as a pain intensity = 50 mm (VAS), within 6 hours from end of surgery.
8.Pre-operative laboratory tests (haematology, blood chemistry, urinalysis), performed within 30 days before inclusion (Visit 1) in the reference ranges or without clinically significant abnormalities as judged by the Investigator.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

General
1.Patients refusing to give a written informed consent.
2.Patients not able to understand the purposes of the study.
3.Patients not reliable, according to the investigator’s opinion.
4.Patients with major psychiatric disorders that could compromise the patient’s participation in the study.
5.Patients previously enrolled in this study or having used any investigational drug/device or participated in any clinical trial in the previous 3 months.
6.Employees of the Investigator or study centre (i.e. Principal Investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or investigator.
7.Pregnant or breast-feeding women.
8.Alcohol or drug abuse within previous 12 months.
9.Clinically significant or unstable concurrent diseases whose sequeleae or treatment might interfere with the study evaluation parameters.

Trial specific
10.Contra-lateral lower 3rd molar extraction or any other concomitant extraction.
11.Surgery performed under general anaesthesia, or sedation (including nitrous oxide by inhalation).
12.Complications occurring during the surgical procedure or in the period before randomisation as judged by the investigator.
13.Acute local or systemic infection at the time of surgery that could confound the post-surgical evaluation.
14.Patients with clinical signs of gastritis, gastro-duodenal ulcer, GI bleeding. Other GI disturbances or disease that in the opinion of the investigator could be negatively affected by the administration of NSAIDs.
15.Clinical signs or history of coagulation disorders that could be negatively affected by NSAIDs administration.
16.Hepatic or renal impairment.
17.Patients with significant cardiac impairment (i.e. severe heart failure, severe ischemic heart disease) history of cerebrovascular disease (i.e. ictus), history or peripheral arterial disease, uncontrolled hypertension, (i.e. not stable = repeated measurements of systolic pressure > 160 mm Hg or diastolic pressure > 95 mm Hg, despite pharmacological treatment).
18.Hypersensitivity to diclofenac or other NSAIDs or to one of the study medication components.
19.Patients under chronic treatment with topical or systemic analgesics/NSAIDs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate non-inferiority of a single s.c. injection of Diclofenac HPBCD 75 mg/1ml to a single i.m. injection of Voltarol® 75mg/3ml in relieving acute moderate-to-severe pain after dental surgery;Secondary Objective: To compare the safety and tolerability of Diclofenac HPBCD 75 mg/1ml s.c to Voltarol® 75mg/3ml i.m.;Primary end point(s): The primary endpoint of the study will be the pain intensity difference (PID) after 1.5 hours following drug administration. Pain intensity difference (PID) is derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI is assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).