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

NCT03836807 | Completed Phase 3 Results

• 1 other identifier: KSL0117
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 3

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 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)

Conditions

Acute Pain

Keywords

dental pain; neuralgia

Outcome Measures

Primary Outcomes (2)

• AUC0-6h of Pain Intensity Between Time 0 (Baseline Value of VAS) and 6 Hours Post-treatment in the ITT Population.

  The primary efficacy endpoint is the pain intensity assessment during 6 hours after molar tooth extraction measured as an area under the curve (AUC) of pain intensity assessed with a visual analogue scale (VAS). More precisely, pain is assessed by a horizontal 100 mm scale where 0 mm = no pain and 100 mm = worst pain imaginable, at the timepoints specified here under in the interval from time 0 (baseline value of VAS) to 6 hours after the drug administration. The AUC0-6h is calculated using the trapezoidal rule. Please note that at 0' (just before taking the first medication) VAS should be \>30 mm. The higher the score, the worse the result.

  time 0', 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) post-treatment

• AUC0-6h of Pain Intensity Between Time 0 (Baseline Value of VAS) and 6 Hours Post-treatment in the PP Population.

  The primary efficacy endpoint is the pain intensity assessment during 6 hours after molar tooth extraction measured as an area under the curve (AUC) of pain intensity assessed with a visual analogue scale (VAS). More precisely, pain is assessed by a horizontal 100 mm scale where 0 = no pain and 100 = worst pain imaginable, at the timepoints specified here under in the interval from time 0 (baseline value of VAS) to 6 hours after the drug administration. The AUC0-6h is calculated using the trapezoidal rule. Please note that at 0' (just before taking the first medication) VAS should be \>30 mm. The higher the score, the worse the result.

  time 0', 5', 10', 15', 30', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) post-treatment

Secondary Outcomes (6)

• Time Profile of Pain Intensity Using VAS Scale

  From time 0 (baseline value of VAS) to 6 hours post-treatment at: 0', 5', 10', 15', 30', 45', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration.

• Time Profile of Pain Relief Using VAS Scale

  From time 0 (baseline value of VAS) to 6 hours post-treatment at: 5', 10', 15', 30', 45', 60' (1 hour), 90' (1.5 hours), 120' (2 hours), 180' (3 hours), 240' (4 hours), 300' (5 hours), and 360' (6 hours) after the drug administration.

• AUC5min-6h of Pain Relief Profile in the ITT and in the PP Populations

  from 5 min to 6 hours post-dose

• Time to First Perceptible Relief (TFPR)

  Day 1

• Time to Meaningful Pain Relief (TMPR)

  Day 1

Study Arms (2)

OKITASK®

EXPERIMENTAL

Single oral administration of Ketoprofen lysine salt 40 mg granules

Drug: OKITASK®

Placebo

PLACEBO COMPARATOR

Single oral administration of placebo matching granules.

Other: Placebo

Interventions

OKITASK® DRUG

A single oral dose of OKITASK® 40 mg was administered to patients within 3 hours after extraction of a molar tooth (VAS ≥ 30 mm). Each patient received one sachet that contained KLS 40 mg (equivalent to 25 mg of ketoprofen). The content of the entire sachet was placed on the patient's tongue and swallowed. A glass of water was immediately administered after the intake of the study drug in order to rinse mouth for all subjects.

Also known as: ketoprofen lysine salt (KLS)

OKITASK®

Placebo OTHER

A single oral dose of matching Placebo was administered to patients within 3 hours after extraction of a molar tooth (VAS ≥ 30 mm). Each patient received one sachet that contained Placebo. The content of the entire sachet was placed on the patient's tongue and swallowed. A glass of water was immediately administered after the intake of the study drug in order to rinse mouth for all subjects.

Also known as: Control

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dompé Farmaceutici S.p.A: lead

Study Sites (3)

LLC "Centre for Interdisciplinary Dentistry and Neurology"

Moscow, 119146, Russia

Location

Federal State Educational Institution "Moscow State Medical Dental University named after Yevdokimov "of the Russian Federation Ministry of Health

Moscow, 127473, Russia

Location

State Autonomous Healthcare Institution of Yaroslavl Region "Clinical Hospital of Emergency care n.a. N.V. Solovyev"

Yaroslavl, Russia

Location

MeSH Terms

Conditions

Acute Pain; Toothache; Neuralgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases; Facial Pain; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Clinical Development & Operations
• Organization: Dompé farmaceutici S.p.A.

clinical.trials@dompe.com

+39 02 583831

Study Officials

• Luigi Lanata, MD

  Dompé SpA Milan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The double-blinding is provided by Placebo that is identical to OKITASK® 40 mg granules. The drug will be packaged and labeled in a manner that will exclude unblinding. IWRS will assign the study drug kit number that should be administrated by the subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 11, 2019
• Study Start: April 4, 2018
• Primary Completion: July 4, 2018
• Study Completion: December 21, 2018
• Last Updated: April 24, 2024
• Results First Posted: April 15, 2024

Record last verified: 2024-04

Locations

RU (3)