Dental Pain 4

• Conditions: post-surgical pain after lower third molar removal.; MedDRA version: 15.0Level: LLTClassification code 10036286Term: Post-operative painSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2012-002996-32-GB
• Lead Sponsor: IBSA Institut Biochimique S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-10
• Last Update Posted: 10 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

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.Patients 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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

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 specific

9.Contralateral lower 3rd molar extraction or any other concomitant extraction.
10.Surgery requiring general anaesthesia or sedation (including nitrous oxide by inhalation).
11.Acute local or systemic infection occurring before surgery that in the investigator’s opinion, could confound the post-surgical evaluation.
12.Patients with clinical signs or history of gastrointestinal disorders (e.g. gastritis, gastro-duodenal ulcer, gastrointestinal bleeding).
13.Clinical signs or history of coagulation disorders.
14.Patients with significant cardiac impairment (e.g. heart failure, ischemic heart disease), history of cerebrovascular disease (e.g. ictus), history of peripheral arterial disease or uncontrolled hypertension, (i.e. not stable = repeated measurements of systolic pressure > 160 mmHg or diastolic pressure > 95 mmHg, despite pharmacological treatment).
15.Hepatic or renal impairment.
16.Hypersensitivity to diclofenac or other NSAIDs.
17.Patients under chronic treatment with topical or systemic analgesics/NSAIDs.
18.Patients who have taken any medication as reported below:

Non-Permitted Medications and wash-out period before surgery:
Systemic NSAIDs or analgesics 24 hours
Major or minor tranquilizers* 24 hours
Muscle relaxers24 hours
Antihistaminesº24 hours
Long-acting NSAIDs 7 days
Opioids7 days
MAO inhibitors2 weeks
Other antidepressants: SSRI, serotonin/norepinephrine reuptake inhibitors, and tricyclics 3 weeks
Corticosteroids (any route of administration)2 months

*Benzodiazepine-type anxiolytics with analgesic or muscle relaxant effect are allowed if their use had been started at least 6 months earlier for other medical reasons (their dose must be maintained unchanged during the study).
ºUnless their use had been started at least 6 months earlier for other medical reasons (their dose must be maintained unchanged during the study).

19.Patients under treatment with any medication that may interact with diclofenac: lithium, digoxin, diuretics, corticosteroids and other NSAIDs, anticoagulants and anti-platelet agents, antidiabetics, methotrexate, cyclosporine, quinolone antimicrobials, phenytoin.

Study & Design

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