Clinical trial NCT02096926: Methodological Validation of Ibuprofen Verses Placebo for Post Operative Pain After Third Molar Extraction Surgery
Official title: Methodological Validation of Ibuprofen Verses Placebo for Post Operative Pain After Third Molar Extraction Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Pain
Keywords: Third Molar Extraction
Lead sponsor: Lotus Clinical Research, LLC
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single center placebo controlled, prospective, randomized study on healthy adults undergoing third molar surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who provide written informed consent prior to enrollment
* Male or female and 18 to 40 years of age
* Patients who are scheduled to undergo elective ipsilateral two (2) third molar extraction surgery under local anesthesia The mandibular third molar must involve full or partial bony impaction confirmed by radiographic evidence
* Female subjects are eligible only if all of the following apply

  * Not pregnant (subjects of child bearing potential must have a negative urine beta human chorionic gonadotropin (β-hCG) pregnancy test before surgery)
  * Not lactating
  * Not planning to become pregnant within the duration of the study
* Patients who are willing and capable of understanding and cooperating with the requirements of the study
* Patients able to understand and communicate in English

Exclusion Criteria:

* Patients who have participated in a Lotus Clinical Research placebo response and pain scale education training program
* Patients with a medical condition that, in the Investigator's opinion, could adversely impact the patient's participation, safety, or conduct of the study such as but not limited to a history of severe renal or hepatic impairment, severe active hepatic disease, other acute or chronic pain conditions, or any other clinically significant medical condition
* Patients who have a known history of intolerance, severe allergy or hypersensitivity to Ibuprofen, opioid analgesics, Lidocaine, or acetaminophen (APAP)
* Patients who have abused any prescription medication or alcohol within two years before the start of the study
* Patients who have surgical complications that could compromise safety of the subject or confound the results of the study
* The subject is taking any corticosteroid chronically (except for an inhaled steroid for pulmonary disease) or has taken systemic corticosteroids within 4 weeks of the proposed date of surgery
* The subject is taking central nervous system (CNS) active drugs such as benzodiazepines, tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) for pain. These drugs are permitted for non-pain indications throughout the study, if the dose has been stable for at least 30 days
* The subject has used acetylsalicylic acid, acetaminophen or nonsteroidal antiinflammatory drug (NSAIDs) within 5 half-lives prior to the planned day of the surgery
* The subject is taking an antihypertensive agent(s) or a diabetic regimen at a dose that has not been stable for at least 28 days.
* Patients who have a history of seizures, or are currently taking anticonvulsants
* Patients who have dysphagia and/or cannot swallow study medication whole
* Patient who is unable to adequately communicate with study staff, properly give informed consent, or otherwise comply with study procedures
* Patient who has participated in another clinical trial of an investigational drug or device within 30 days of screening visit or is schedule to receive an investigational product while participating in the study

Primary outcomes:
measure: Sum of pain intensity difference (SPID)6
timeFrame: 6 hours
Secondary outcomes:
measure: Sum of pain intensity difference (SPID) 3
timeFrame: 3 hour
Other outcomes:
measure: Total Pain Relief (TOTPAR) 6
timeFrame: 6 hours
measure: Patient Global Assessment
timeFrame: 6 hours post study drug administration
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Research, LLC
state: California
Study officials:
affiliation: Lotus Clinical Research, LLC
name: Sonia Singla, DO
role: PRINCIPAL_INVESTIGATOR
References: