study to evaluate the onset of pain response after administration of ketoprofen, in male and female subjects with acute pain after removal of a molar tooth

Randomized, single dose, placebo-controlled, double-blind, parallel group study to evaluate the onset of pain response after administration of ketoprofen lysine salt 40 mg, in male and female subjects with acute pain after removal of a molar tooth - Ketoprofen - pain relief onset after molar extraction

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002114-38-IT

Enrollment

120

Registered

2021-01-15

Start date

2019-09-04

Completion date

Unknown

Last updated

2021-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pain management in odontoiatry MedDRA version: 21.1 Level: PT Classification code 10062132 Term: Tooth extraction System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Product Name: ketoprofene sale di lisina Product Code: [KSL] Pharmaceutical Form: Granules for oral solution INN or Proposed INN: Ketoprofen lysine salt CAS Number: 173011-11-5 Current Sponsor code: K

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and age: men/women, 18-70 year old inclusive 3. Surgery: removal of a single molar tooth (not impacted) 4. Post-operative pain: post-operative pain of intensity >30 and =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. Surgery: extraction of impacted and dystopic teeth, tooth preserving operations, apically positioning flap/vestibuloplasty with free gingival graft from the palate, more than one tooth extraction in the same extraction procedure 2. General health: general health conditions unsuitable for a safe administration of conscious sedation to out-patients 3. Allergy: ascertained or presumptive hypersensitivity to the active principles (ketoprofen and paracetamol as rescue medication) and/or formulations' ingredients; history of anaphylaxis to drugs (in particular to NSAIDs) or allergic reactions in general, which the investigator considers may affect the outcome of the study 4. Diseases: significant history of renal, hepatic, gastrointestinal (in particular, active peptic ulcer or haemorrhage, history of gastro-intestinal haemorrhages, ulcerations or perforations or chronic dyspepsia) cardiovascular with the exclusion of hypertension and coronary artery disease, haematological, endocrine with the exclusion of diabetes, autoimmune or neurological diseases that may interfere with the aim of the study. History of bronchial asthma 5. Medications: non-steroidal anti-inflammatory drugs, among which in particular ketoprofen, paracetamol and acetylsalicylic acid, taken in the 3 h before surgery. Slow-release analgesics taken in the 24 h before surgery 6. Investigative drug studies: participation in the evaluation of any investigational product for 1 month before this study or previous participation in the present study 7. Drug, alcohol: history of drug and/or alcohol abuse [>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015] 8. Pregnancy (women only): positive or missing pregnancy test at screening, pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to define the onset of pain relief after administration of a single oral dose of KLS or placebo in male and female subjects with acute pain syndrome after removal of a molar tooth;Secondary Objective: - To compare the time to first perceptible relief (TFPR) and the time to first meaningful relief (TFMR) after administration of a single oral dose of 40 mg of KLS versus placebo in male and female subjects with acute pain syndrome after removal of a molar tooth. - To compare the proportions of subjects with TFPR and TFMR <10 min and <15 min after administration of a single oral dose of 40 mg of KLS versus placebo in male and female subjects with acute pain syndrome after removal of a molar tooth. - To compare the time to rescue medication (REMD) after administration of a single oral dose of 40 mg of KLS versus placebo in male and female subjects with acute pain syndrome after removal of a molar tooth.;Primary end point(s): A reduction in pain intensity evaluated by a horizontal 100-mm VAS at any single timepoint over a 30 min period after treatment.;Timepoint(s) of evaluation of this end point: 30 min period after treatment.	—

Measure

Time frame

Main Objective: The primary objective of this study is to define the onset of pain relief after administration of a single oral dose of KLS or placebo in male and female subjects with acute pain syndrome after removal of a molar tooth;Secondary Objective: - To compare the time to first perceptible relief (TFPR) and the time to first meaningful relief (TFMR) after administration of a single oral dose of 40 mg of KLS versus placebo in male and female subjects with acute pain syndrome after removal of a molar tooth. - To compare the proportions of subjects with TFPR and TFMR <10 min and <15 min after administration of a single oral dose of 40 mg of KLS versus placebo in male and female subjects with acute pain syndrome after removal of a molar tooth. - To compare the time to rescue medication (REMD) after administration of a single oral dose of 40 mg of KLS versus placebo in male and female subjects with acute pain syndrome after removal of a molar tooth.;Primary end point(s): A reduction in pain intensity evaluated by a horizontal 100-mm VAS at any single timepoint over a 30 min period after treatment.;Timepoint(s) of evaluation of this end point: 30 min period after treatment.

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Secondary

Measure	Time frame
Secondary end point(s): Comparison of TFPR and TFMR between treatments; - Proportion of subjects reporting a TFPR <10 min in each treatment group - Proportion of subjects reporting a TFMR <10 min in each treatment group - Proportion of subjects reporting a TFPR <15 min in each treatment group - Proportion of subjects reporting a TFMR <15 min in each treatment group; Proportions of subjects reporting no need for the rescue medication.;Timepoint(s) of evaluation of this end point: 30 min period after treatment.; <10 min / 15 min after the treatment; 30 min from the treatment	—

Measure

Time frame

Secondary end point(s): Comparison of TFPR and TFMR between treatments; - Proportion of subjects reporting a TFPR <10 min in each treatment group - Proportion of subjects reporting a TFMR <10 min in each treatment group - Proportion of subjects reporting a TFPR <15 min in each treatment group - Proportion of subjects reporting a TFMR <15 min in each treatment group; Proportions of subjects reporting no need for the rescue medication.;Timepoint(s) of evaluation of this end point: 30 min period after treatment.; <10 min / 15 min after the treatment; 30 min from the treatment

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Countries

Italy

Contacts

Public ContactClinical Project Unit

CROSS Research SA

angelo.vaccani@croalliance.com+41916300510

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026