CompletedPhase 3

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

Russia70 participantsStarted 2018-04-04

Plain-language 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)

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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);

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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.

Timeframe: 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

Trial details

NCT IDNCT03836807

SponsorDompé Farmaceutici S.p.A

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-07-04

Results submitted2022-09-20

View on ClinicalTrials.gov More Acute Pain trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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);

What they're measuring

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

Timeframe: 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.

Timeframe: 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

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria