Study to Assess the Kinetic of the Analgesic Effect and Tolerability of Eschscholtzia Californica Versus Ibuprofen and Placebo in the Treatment of Pain After Surgery of the Third Molar

July 11, 2014 updated by: Boehringer Ingelheim

Short Term Double Blind Randomised Controlled Study to Assess the Kinetic of the Analgesic Effect and the Tolerability of Eschscholtzia Californica 500 mg and 1000 mg Versus Ibuprofen 200 mg and Placebo in the Treatment of Pain After Surgery of the Third Molar

Study to determine the kinetic of the analgesic effect of 500 mg and 1000 mg of Eschscholtzia Californica per os and placebo in patients undergoing dental surgery over an observation period of 6 hours. In a secondary analysis, kinetic of analgesic effect comparison between Eschscholtzia californica 500 mg, 1000 mg and Ibuprofen 200 mg

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female above 18 or below 61 years old
  • Patient having to undergo a third molar removal from the lower jaw under local troncular anesthesia (articaine + adrenaline)

  • Type of inclusion of the molar:

    • Molar in the sub-mucosa: Type II
    • Molar partially impacted in the bone: Type III
  • Patient suffering from at least moderate to severe pain after surgical removal of an impacted third molar, defined by a 4 point verbal rating scale
  • Patient's informed consent in accordance with the French legislation
  • Patient affiliated to the Social Security System

Exclusion Criteria:

  • Pregnant or nursing female or female of childbearing potential not using a medically approved method of contraception like oral contraception or intrauterine contraceptive device
  • Patient with any pathology inducing a chronic pain
  • Patient having taken any drug with analgesic properties in the 24 hours previous to the administration of the study drug
  • Patient with concomitant administration of other Non-Steroid Anti-Inflammatory Drug(s) (NSAIDs) or analgesic agents
  • Patients treated by an antibiotic different from those required for the dental surgery which administration is started 48 hours prior to the tooth removal
  • Patient with significant peri-operative complication judged by the investigator
  • Patient with anti-coagulants concomitant treatment (including heparin)
  • Patient with severe hepatic or renal insufficiency which judged to be regarded as clinically relevant by the investigator or any known clinically significant disease which may induce a risk for the patient in participating to the trial
  • Patient with mental disturbance
  • Patient with non controlled diabetes
  • Patient with acute infections
  • Patient with respiratory insufficiency, asthma
  • Patient unable to comply with the protocol
  • Patient having taken part in a clinical trial in the past month or already participating in another trial
  • Patient deprived of their freedom by a judicial or administrative decision
  • Adults under guardianship
  • Persons hospitalized in medical or social establishments
  • Patients in emergency situation
  • Patient with a known or suspected hypersensitivity to the trial medication, to Ibuprofen, Paracetamol, anesthetic used (articaine, adrenaline), to the preventive antibiotic treatment (penicillin, macrolides)

Post study exclusion period: the patient will not be able to participate in any other trial for a period of two weeks after the end of this trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Drug: Ibuprofen Placebo
Drug: Eschscholtzia Californica - high dose Placebo
EXPERIMENTAL: Eschscholtzia Californica - low dose
Drug: Ibuprofen Placebo
Drug: Eschscholtzia Californica - low dose
Drug: Eschscholtzia Californica - low dose Placebo
EXPERIMENTAL: Eschscholtzia Californica - high dose
Drug: Ibuprofen Placebo
Drug: Eschscholtzia Californica - high dose
ACTIVE_COMPARATOR: Ibuprofen
Drug: Ibuprofen
Drug: Eschscholtzia Californica - high dose Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
VAS-SPID - summed pain intensity differences (SPID) on a VAS (Visual Analogue Scale)
Time Frame: Baseline, up to 6 hours after drug intake
Baseline, up to 6 hours after drug intake

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pain intensity differences (PID) on a VAS
Time Frame: Baseline, up to 6 hours after drug intake
Baseline, up to 6 hours after drug intake
Pain intensity difference in the groups on a VAS
Time Frame: Baseline, 2 hours after drug intake
Baseline, 2 hours after drug intake
Time point for maximum pain intensity difference on VAS
Time Frame: Baseline, up to 6 hours after drug intake
Baseline, up to 6 hours after drug intake
Number of patients with a pain decrease of at least 50 % over the all period of observation on a VAS
Time Frame: Baseline, up to 6 hours after drug intake
Baseline, up to 6 hours after drug intake
Pain relief at each observed time points on a 5-point verbal rating scale (VRS)
Time Frame: up to 6 hours after drug intake
up to 6 hours after drug intake
Total pain relief on a 5-point VRS
Time Frame: up to 6 hours after drug intake
up to 6 hours after drug intake
Global efficacy assessment on a 4-points VRS
Time Frame: 2 and 6 hours after drug intake, day 7
2 and 6 hours after drug intake, day 7
Number of patients requiring a rescue medication
Time Frame: Day 1
Day 1
Number of patients with adverse events
Time Frame: up to 9 days after treatment
up to 9 days after treatment
Assessment of tolerability by investigator on a 4-point VRS
Time Frame: 6 hours after drug intake, day 7
6 hours after drug intake, day 7
Assessment of tolerability by subject on a 4-point VRS
Time Frame: 6 hours after drug intake, day 7
6 hours after drug intake, day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 1998

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 1999

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2014

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1120.3

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