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

NCT02187588 | Completed Phase 2

• 1 other identifier: 1120.3
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• VAS-SPID - summed pain intensity differences (SPID) on a VAS (Visual Analogue Scale)

  Baseline, up to 6 hours after drug intake

Secondary Outcomes (11)

• 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

Study Arms (4)

Eschscholtzia Californica - low dose

EXPERIMENTAL

Drug: Eschscholtzia Californica - low dose; Drug: Eschscholtzia Californica - low dose Placebo; Drug: Ibuprofen Placebo

Eschscholtzia Californica - high dose

EXPERIMENTAL

Drug: Eschscholtzia Californica - high dose; Drug: Ibuprofen Placebo

Ibuprofen

ACTIVE COMPARATOR

Drug: Ibuprofen; Drug: Eschscholtzia Californica - high dose Placebo

Placebo

PLACEBO COMPARATOR

Drug: Eschscholtzia Californica - high dose Placebo; Drug: Ibuprofen Placebo

Interventions

Eschscholtzia Californica - low dose DRUG

Eschscholtzia Californica - low dose

Eschscholtzia Californica - high dose DRUG

Eschscholtzia Californica - high dose

Ibuprofen DRUG

Ibuprofen

Eschscholtzia Californica - low dose Placebo DRUG

Eschscholtzia Californica - low dose

Eschscholtzia Californica - high dose Placebo DRUG

Ibuprofen; Placebo

Ibuprofen Placebo DRUG

Eschscholtzia Californica - high dose; Eschscholtzia Californica - low dose; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 11, 2014
• Study Start: February 1, 1998
• Primary Completion: May 1, 1999
• Last Updated: July 14, 2014

Record last verified: 2014-07