Phase 3
N=70
A Study to Assess Efficacy and Tolerability of Ketoprofen 40 mg Granules vs Placebo
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT03836807 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: AUC0-6h of Pain Intensity Between Time 0 (Baseline Value of VAS) and 6 Hours Post-treatment in the ITT Population. — 5031; 7593 mm*min — p=0.020
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- OKITASK® (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dompé Farmaceutici S.p.A
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUC0-6h of Pain Intensity Between Time 0 (Baseline Value of VAS) and 6 Hours Post-treatment in the ITT Population. |
5031; 7593 | 0.020 sig |
| PRIMARY AUC0-6h of Pain Intensity Between Time 0 (Baseline Value of VAS) and 6 Hours Post-treatment in the PP Population. |
5099; 7593 | 0.026 sig |
| SECONDARY Time Profile of Pain Intensity Using VAS Scale |
45.3; 45.5; 45.2; 43.9; 40.4; 40.7 | 0.914 |
| SECONDARY Time Profile of Pain Relief Using VAS Scale |
12.7; 10.1; 20.3; 16.0; 31.6; 22.7 | 0.361 |
| SECONDARY AUC5min-6h of Pain Relief Profile in the ITT and in the PP Populations |
27445; 22103; 27362; 22103 | 0.007 sig |
| SECONDARY Time to First Perceptible Relief (TFPR) |
18.5; 31.4 | 0.004 sig |
| SECONDARY Time to Meaningful Pain Relief (TMPR) |
36.9; 58.4 | 0.002 sig |
| SECONDARY Number of Participants With an Overall Assessment Score of "Very Good", "Satisfactory", "Poor" or "Very Poor" on a (Patient's Overall Assessment) on a 5-point Scale |
6; 2; 22; 24; 7; 9 | 0.480 |
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)
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT03836807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.