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Completed

NCT Number: NCT02187588

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eschscholtzia Californica - low dose

Drug

Eschscholtzia Californica - high dose

Drug

Ibuprofen

Drug

Eschscholtzia Californica - low dose Placebo

Drug

Eschscholtzia Californica - high dose Placebo

Drug

Ibuprofen placebo

Drug

Primary outcomes

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

    Time frame: Baseline, up to 6 hours after drug intake

Secondary outcomes

  1. Pain intensity differences (PID) on a VAS

    Time frame: Baseline, up to 6 hours after drug intake

  2. Pain intensity difference in the groups on a VAS

    Time frame: Baseline, 2 hours after drug intake

  3. Time point for maximum pain intensity difference on VAS

    Time frame: Baseline, up to 6 hours after drug intake

  4. 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

  5. Pain relief at each observed time points on a 5-point verbal rating scale (VRS)

    Time frame: up to 6 hours after drug intake

  6. Total pain relief on a 5-point VRS

    Time frame: up to 6 hours after drug intake

  7. Global efficacy assessment on a 4-points VRS

    Time frame: 2 and 6 hours after drug intake, day 7

  8. Number of patients requiring a rescue medication

    Time frame: Day 1

  9. Number of patients with adverse events

    Time frame: up to 9 days after treatment

  10. Assessment of tolerability by investigator on a 4-point VRS

    Time frame: 6 hours after drug intake, day 7

  11. Assessment of tolerability by subject on a 4-point VRS

    Time frame: 6 hours after drug intake, day 7

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
1999
First posted
Jul 11, 2014
Registry last updated
Jul 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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