A Study to Assess Efficacy and Tolerability of Ketoprofen 40 mg Granules vs Placebo

• Status: Completed
• Trial end date: 2018-12-21
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective:

To assess the efficacy of OKITASK® 40 mg granules versus Placebo in patients with acute pain syndrome after removal of one molar tooth by comparing AUC0-6h of posttreatment pain profile measured by VAS.

Secondary objectives:

To assess the following efficacy and safety parameters of OKITASK® 40 mg granules versus Placebo in patients with acute pain syndrome after removal of one molar tooth:

• Time profile of pain and time profile of pain relief using VAS scales

• Time to first perceptible pain relief (TFPR) and time to meaningful pain relief (TMPR)

• Proportion of patients requiring rescue medication (analgesia) and time to rescue analgesia

• Patient's overall assessment

• Rate of adverse events (AE)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dompé Farmaceutici S.p.A
• Treatments: Ketoprofen; Ketoprofen lysine

Criteria

Inclusion Criteria:

1. Signed Informed Consent Form;

2. Male and female, from 18 years to 65 years (inclusively);

3. Subjects who undergo removal of a non-impacted molar tooth within 3 hours before randomization in the study;

4. Subjects in generally good health (based upon criteria for safe administration of outpatient conscious sedation);

5. Subjects requesting relief for postoperative pain within 3 h after the tooth extraction (VAS ≥30 mm);

6. Subjects willing to undergo observation period for up to 9 hours after the tooth extraction;

7. Ability to complete a 100 mm VAS and a category scale during the observation period (about 9 hours);

8. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study;

9. Contraception (for females): females of child-bearing potential must be using at least one reliable method of contraception, as follows:

1. hormonal oral, implantable, transdermal, or injectable contraceptives;

2. a non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide; or should have:

3. a male sexual partner who agrees to use a male condom with spermicide;

4. a sterile sexual partner.

Exclusion Criteria:

1. Subjects undergoing extraction of impacted and dystopic teeth, tooth preserving operations, apically positioning flap/vestibuloplasty with free gingival graft from the palate;

2. Subjects undergoing more than one tooth extraction in the same extraction procedure;

3. Subjects undergoing dental implantation simultaneously with tooth extraction;

4. Allergy: ascertained or presumptive hypersensitivity to the active substances (ketoprofen and paracetamol as rescue medication) and/or formulations' ingredients; history of hypersensitivity to drugs (in particular to NSAIDs) or allergic reactions in general, which the Investigator considers may affect the outcome of the study;

5. Diseases: relevant history of renal, hepatic, cardiovascular, respiratory (including asthma), skin, haematological, endocrine, gastro-enteric and genitourinary tract or neurological and autoimmune diseases, that may interfere with the aim of the study;

6. Medications: non-steroidal anti-inflammatory drugs (NSAIDS) and other analgesics [in particular ketoprofen, paracetamol and acetylsalicylic acid (ASA)], antihistamines, sedating medications, including herbal and BASs, taken 48 h beforesurgery;

7. Investigational drug trials: participation in the evaluation of any drug within 3 months before screening (including the last study procedure);

8. Relevant history of drug and alcohol abuse.

9. Positive Pregnancy test in female patients of childbearing potential (including patients in post-menopausal status for less than 2 years).