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

NCT03836807 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-04-24

Study results available
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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

Interventions

DRUG

OKITASK®

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.

OTHER

Placebo

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.

Sponsors & Collaborators

  • Dompé Farmaceutici S.p.A

    lead INDUSTRY

Principal Investigators

  • Luigi Lanata, MD · Dompé SpA Milan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-04
Primary Completion
2018-07-04
Completion
2018-12-21

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03836807 on ClinicalTrials.gov