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

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: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Ibuprofen; Drug: Ibuprofen Placebo; Drug: Eschscholtzia Californica - low dose; Drug: Eschscholtzia Californica - low dose Placebo; Drug: Eschscholtzia Californica - high dose; Drug: Eschscholtzia Californica - high dose Placebo

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
VAS-SPID - summed pain intensity differences (SPID) on a VAS (Visual Analogue Scale)	Baseline, up to 6 hours after drug intake

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain intensity differences (PID) on a VAS	Baseline, up to 6 hours after drug intake
Pain intensity difference in the groups on a VAS	Baseline, 2 hours after drug intake
Time point for maximum pain intensity difference on VAS	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	Baseline, up to 6 hours after drug intake
Pain relief at each observed time points on a 5-point verbal rating scale (VRS)	up to 6 hours after drug intake
Total pain relief on a 5-point VRS	up to 6 hours after drug intake
Global efficacy assessment on a 4-points VRS	2 and 6 hours after drug intake, day 7
Number of patients requiring a rescue medication	Day 1
Number of patients with adverse events	up to 9 days after treatment
Assessment of tolerability by investigator on a 4-point VRS	6 hours after drug intake, day 7
Assessment of tolerability by subject on a 4-point VRS	6 hours after drug intake, day 7

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 1998
• Primary Completion (ACTUAL): May 1, 1999

Study Registration Dates

• First Submitted: July 10, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (ESTIMATE): July 11, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 14, 2014
• Last Update Submitted That Met QC Criteria: July 11, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: 1120.3