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A Study to Assess Efficacy and Tolerability of Ketoprofen 40 mg Granules vs Placebo (KSL0117)

Primary Purpose

Acute Pain

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Ketoprofen
Placebo
Sponsored by
Dompé Farmaceutici S.p.A
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed Informed Consent Form;
  2. Male and female, from 18 years to 65 years (inclusively);
  3. Subjects who undergo removal of a non-impacted molar tooth within 3 hours before randomization in the study;
  4. Subjects in generally good health (based upon criteria for safe administration of outpatient conscious sedation);
  5. Subjects requesting relief for postoperative pain within 3 h after the tooth extraction (VAS ≥30 mm);
  6. Subjects willing to undergo observation period for up to 9 hours after the tooth extraction;
  7. Ability to complete a 100 mm VAS and a category scale during the observation period (about 9 hours);
  8. 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;

  9. Contraception (for females): females of child-bearing potential must be using at least one reliable method of contraception, as follows:

    1. hormonal oral, implantable, transdermal, or injectable contraceptives;
    2. 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:
    3. a male sexual partner who agrees to use a male condom with spermicide;
    4. a sterile sexual partner.

Exclusion Criteria:

  1. Subjects undergoing extraction of impacted and dystopic teeth, tooth preserving operations, apically positioning flap/vestibuloplasty with free gingival graft from the palate;
  2. Subjects undergoing more than one tooth extraction in the same extraction procedure;
  3. Subjects undergoing dental implantation simultaneously with tooth extraction;
  4. 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;
  5. 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;
  6. 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 beforesurgery;
  7. Investigational drug trials: participation in the evaluation of any drug within 3 months before screening (including the last study procedure);
  8. Relevant history of drug and alcohol abuse.
  9. Positive Pregnancy test in female patients of childbearing potential (including patients in post-menopausal status for less than 2 years).

Sites / Locations

  • LLC "Centre for Interdisciplinary Dentistry and Neurology"
  • Federal State Educational Institution "Moscow State Medical Dental University named after Yevdokimov "of the Russian Federation Ministry of Health
  • State Autonomous Healthcare Institution of Yaroslavl Region "Clinical Hospital of Emergency care n.a. N.V. Solovyev"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketoprofen

Placebo

Arm Description

Single oral administration of Ketoprofen lysine salt 40 mg granules

Single oral administration of placebo granules

Outcomes

Primary Outcome Measures

AUC0-6h of pain profile
Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS): 0 no pain - 100 worst pain imaginable at: 0' (just before taking the first medication VAS should be >30 mm) and 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) after the drug administration.

Secondary Outcome Measures

Time profile of pain.
Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS): 0 no pain - 100 worst pain imaginable.
Time profile of pain relief
Pain relief will be assessed by a horizontal 100 mm VAS: 0 no relief - 100 maximum relief.
Time to first perceptible relief (TFPR)
TFPR will be measured by stopwatches. Upon study drug administration the patients will immediately start a stopwatch, once the patient feels first perceptible pain relief.
Time to meaningful pain relief (TMPR)
TFPR will be measured by stopwatches. Upon study drug administration the patients will immediately start a stopwatch, once the patient feels first perceptible pain relief.
Proportion of patients requiring rescue medication (analgesia)
Should the patient require rescue medication at any time during 6 hours post-dose, the last VAS measurement and patient's overall assessment will be performed before the rescue medication dosing. Subjects will be encouraged to postpone the rescue medication until after 1 hour post-dose.
Time to rescue analgesia
In the event of poor pain control, subjects will be allowed access to rescue medication for analgesia (Paracetamol 500-1000 mg). Time to REMD (rescue) with an alternative analgesic, if it occurred, will be recorded. Subject will be encouraged to postpone the rescue medication until after 1 h post dose. If Paracetamol 500-1000 mg is not effective, the patient will be allowed to take another dose of Paracetamol 500-1000 mg every 6-8 hours; maximum daily dose is 4000 mg.
Patient's overall assessment
Patient's overall assessment (5-point scale): 1 = very good, 2 = good, 3= satisfactory, 4 = poor, 5 = very poor. If a patient takes rescue medication, the Patient's overall assessment will be performed after the last VAS assessment.

Full Information

First Posted
January 28, 2019
Last Updated
February 8, 2019
Sponsor
Dompé Farmaceutici S.p.A
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1. Study Identification

Unique Protocol Identification Number
NCT03836807
Brief Title
A Study to Assess Efficacy and Tolerability of Ketoprofen 40 mg Granules vs Placebo
Acronym
KSL0117
Official Title
A Multicenter, Double Blind, Randomised, Parallel Study to Assess Efficacy and Tolerability After Single Administration of Ketoprofen Lysine Salt 40 mg Granules vs Placebo in Subjects With Acute Pain Syndrome After Removal of Molar Teeth
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 4, 2018 (Actual)
Primary Completion Date
July 24, 2018 (Actual)
Study Completion Date
December 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dompé Farmaceutici S.p.A

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)
Detailed Description
This is a multicenter, double blind, randomised, parallel groups study to assess the efficacy and tolerability after single oral administration of Ketoprofen lysine salt 40 mg granules versus Placebo in male and female subjects with acute pain syndrome after removal of molar teeth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketoprofen
Arm Type
Experimental
Arm Description
Single oral administration of Ketoprofen lysine salt 40 mg granules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single oral administration of placebo granules
Intervention Type
Drug
Intervention Name(s)
Ketoprofen
Other Intervention Name(s)
Okitask, ketoprofen lysine salt (KLS)
Intervention Description
40 mg KLS granules (corresponding to 25 mg ketoprofen)
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control
Intervention Description
0 mg KLS granules
Primary Outcome Measure Information:
Title
AUC0-6h of pain profile
Description
Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS): 0 no pain - 100 worst pain imaginable at: 0' (just before taking the first medication VAS should be >30 mm) and 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) after the drug administration.
Time Frame
From time 0 (baseline value of VAS) to 6 hours post-treatment
Secondary Outcome Measure Information:
Title
Time profile of pain.
Description
Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS): 0 no pain - 100 worst pain imaginable.
Time Frame
From time 0 (baseline value of VAS) to 6 hours post-treatment at: 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) after the drug administration.
Title
Time profile of pain relief
Description
Pain relief will be assessed by a horizontal 100 mm VAS: 0 no relief - 100 maximum relief.
Time Frame
From time 0 (baseline value of VAS) to 6 hours post-treatment at: 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) after the drug administration.
Title
Time to first perceptible relief (TFPR)
Description
TFPR will be measured by stopwatches. Upon study drug administration the patients will immediately start a stopwatch, once the patient feels first perceptible pain relief.
Time Frame
Day 1
Title
Time to meaningful pain relief (TMPR)
Description
TFPR will be measured by stopwatches. Upon study drug administration the patients will immediately start a stopwatch, once the patient feels first perceptible pain relief.
Time Frame
Day 1
Title
Proportion of patients requiring rescue medication (analgesia)
Description
Should the patient require rescue medication at any time during 6 hours post-dose, the last VAS measurement and patient's overall assessment will be performed before the rescue medication dosing. Subjects will be encouraged to postpone the rescue medication until after 1 hour post-dose.
Time Frame
Day 1
Title
Time to rescue analgesia
Description
In the event of poor pain control, subjects will be allowed access to rescue medication for analgesia (Paracetamol 500-1000 mg). Time to REMD (rescue) with an alternative analgesic, if it occurred, will be recorded. Subject will be encouraged to postpone the rescue medication until after 1 h post dose. If Paracetamol 500-1000 mg is not effective, the patient will be allowed to take another dose of Paracetamol 500-1000 mg every 6-8 hours; maximum daily dose is 4000 mg.
Time Frame
Day 1
Title
Patient's overall assessment
Description
Patient's overall assessment (5-point scale): 1 = very good, 2 = good, 3= satisfactory, 4 = poor, 5 = very poor. If a patient takes rescue medication, the Patient's overall assessment will be performed after the last VAS assessment.
Time Frame
Day 1 at 360' or > 60' in case of early discontinuation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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 beforesurgery; 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro P. Ferrari, Pharm D
Organizational Affiliation
Dompé SpA Milan
Official's Role
Study Director
Facility Information:
Facility Name
LLC "Centre for Interdisciplinary Dentistry and Neurology"
City
Moscow
ZIP/Postal Code
119146
Country
Russian Federation
Facility Name
Federal State Educational Institution "Moscow State Medical Dental University named after Yevdokimov "of the Russian Federation Ministry of Health
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
State Autonomous Healthcare Institution of Yaroslavl Region "Clinical Hospital of Emergency care n.a. N.V. Solovyev"
City
Yaroslavl
Country
Russian Federation

12. IPD Sharing Statement

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

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