Status:
COMPLETED
A Study to Assess Efficacy and Tolerability of Ketoprofen 40 mg Granules vs Placebo
Lead Sponsor:
Dompé Farmaceutici S.p.A
Conditions:
Acute Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 pr...
Detailed Description
This is a multicenter, double blind, randomized, parallel groups study to assess the efficacy and tolerability after single oral administration of Ketoprofen lysine salt 40 mg granules versus Placebo ...
Eligibility Criteria
Inclusion
- Signed Informed Consent Form;
- Male and female, from 18 years to 65 years (inclusively);
- Subjects who undergo removal of a non-impacted molar tooth within 3 hours before randomization in the study;
- Subjects in generally good health (based upon criteria for safe administration of outpatient conscious sedation);
- Subjects requesting relief for postoperative pain within 3 h after the tooth extraction (VAS ≥30 mm);
- Subjects willing to undergo observation period for up to 9 hours after the tooth extraction;
- Ability to complete a 100 mm VAS and a category scale during the observation period (about 9 hours);
- 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;
- Contraception (for females): females of child-bearing potential must be using at least one reliable method of contraception, as follows:
- hormonal oral, implantable, transdermal, or injectable contraceptives;
- 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:
- a male sexual partner who agrees to use a male condom with spermicide;
- a sterile sexual partner.
Exclusion
- Subjects undergoing extraction of impacted and dystopic teeth, tooth preserving operations, apically positioning flap/vestibuloplasty with free gingival graft from the palate;
- Subjects undergoing more than one tooth extraction in the same extraction procedure;
- Subjects undergoing dental implantation simultaneously with tooth extraction;
- 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;
- 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;
- 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 before surgery;
- Investigational drug trials: participation in the evaluation of any drug within 3 months before screening (including the last study procedure);
- Relevant history of drug and alcohol abuse.
- Positive Pregnancy test in female patients of childbearing potential (including patients in post-menopausal status for less than 2 years).
Key Trial Info
Start Date :
April 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2018
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03836807
Start Date
April 4 2018
End Date
December 21 2018
Last Update
April 24 2024
Active Locations (3)
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1
LLC "Centre for Interdisciplinary Dentistry and Neurology"
Moscow, Russia, 119146
2
Federal State Educational Institution "Moscow State Medical Dental University named after Yevdokimov "of the Russian Federation Ministry of Health
Moscow, Russia, 127473
3
State Autonomous Healthcare Institution of Yaroslavl Region "Clinical Hospital of Emergency care n.a. N.V. Solovyev"
Yaroslavl, Russia