PainPhase 2NCT02187588
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
A Phase 2 study testing Eschscholtzia Californica - low dose, Eschscholtzia Californica - high dose and Ibuprofen in people with Pain, run by Boehringer Ingelheim.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain
- What is being tested?
- Eschscholtzia Californica - low dose, Eschscholtzia Californica - high dose and Ibuprofen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 1998to May 1999
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
About this study
Official 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
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eschscholtzia Californica - low doseDrug
Eschscholtzia Californica - high doseDrug
IbuprofenDrug
Eschscholtzia Californica - low dose PlaceboDrug
Eschscholtzia Californica - high dose PlaceboDrug
Ibuprofen PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Eschscholtzia Californica - low dose | Experimental | Not described Receives: Drug: Eschscholtzia Californica - low dose; Drug: Eschscholtzia Californica - low dose Placebo; Drug: Ibuprofen Placebo |
| Eschscholtzia Californica - high dose | Experimental | Not described Receives: Drug: Eschscholtzia Californica - high dose; Drug: Ibuprofen Placebo |
| Ibuprofen | Active comparator | Not described Receives: Drug: Ibuprofen; Drug: Eschscholtzia Californica - high dose Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Eschscholtzia Californica - high dose Placebo; Drug: Ibuprofen Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS-SPID - summed pain intensity differences (SPID) on a VAS (Visual Analogue Scale)
Measured: Baseline, up to 6 hours after drug intake
Secondary outcomes (11)
Pain intensity differences (PID) on a VAS
Measured: Baseline, up to 6 hours after drug intake
Pain intensity difference in the groups on a VAS
Measured: Baseline, 2 hours after drug intake
Time point for maximum pain intensity difference on VAS
Measured: 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
Measured: Baseline, up to 6 hours after drug intake
Pain relief at each observed time points on a 5-point verbal rating scale (VRS)
Measured: up to 6 hours after drug intake
Total pain relief on a 5-point VRS
Measured: up to 6 hours after drug intake
Global efficacy assessment on a 4-points VRS
Measured: 2 and 6 hours after drug intake, day 7
Number of patients requiring a rescue medication
Measured: Day 1
Number of patients with adverse events
Measured: up to 9 days after treatment
Assessment of tolerability by investigator on a 4-point VRS
Measured: 6 hours after drug intake, day 7
Assessment of tolerability by subject on a 4-point VRS
Measured: 6 hours after drug intake, day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startFeb 1998
- Primary completionMay 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187588
- Sponsor's protocol ID
- 1120.3
- Status last verified
- Jul 2014
- First submitted
- 10 Jul 2014
- Last updated
- 14 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02187588
- Acronym / sponsor ID
- 1120.3
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 1998
- Primary completion
- May 1999 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
VAS-SPID - summed pain intensity differences (SPID) on a VAS (Visual Analogue Scale)
Time frame: Baseline, up to 6 hours after drug intake
11 secondary outcomes
Pain intensity differences (PID) on a VAS
Time frame: 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
Time point for maximum pain intensity difference on VAS
Time frame: 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
Pain relief at each observed time points on a 5-point verbal rating scale (VRS)
Time frame: up to 6 hours after drug intake
Total pain relief on a 5-point VRS
Time frame: 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
Number of patients requiring a rescue medication
Time frame: Day 1
Number of patients with adverse events
Time frame: 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
Assessment of tolerability by subject on a 4-point VRS
Time frame: 6 hours after drug intake, day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2014.
- Related InfoLink provided by the sponsor.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eschscholtzia Californica - low dose, Eschscholtzia Californica - high dose and Ibuprofen in people with Pain, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS-SPID - summed pain intensity differences (SPID) on a VAS (Visual Analogue Scale) (time frame: Baseline, up to 6 hours after drug intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2014.