Methodological Validation of Ibuprofen Verses Placebo for Post Operative Pain After Third Molar Extraction Surgery
Primary Purpose
Dental Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Dental Pain focused on measuring Third Molar Extraction
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
Sites / Locations
- Lotus Clinical Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Ibuprofen
Arm Description
placebo
400 mg PO
Outcomes
Primary Outcome Measures
Sum of pain intensity difference (SPID)6
Secondary Outcome Measures
Sum of pain intensity difference (SPID) 3
Full Information
NCT ID
NCT02096926
First Posted
March 24, 2014
Last Updated
April 6, 2015
Sponsor
Lotus Clinical Research, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02096926
Brief Title
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
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lotus Clinical Research, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single center placebo controlled, prospective, randomized study on healthy adults undergoing third molar surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain
Keywords
Third Molar Extraction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
Ibuprofen
Arm Type
Active Comparator
Arm Description
400 mg PO
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
400 mg PO
Primary Outcome Measure Information:
Title
Sum of pain intensity difference (SPID)6
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Sum of pain intensity difference (SPID) 3
Time Frame
3 hour
Other Pre-specified Outcome Measures:
Title
Total Pain Relief (TOTPAR) 6
Time Frame
6 hours
Title
Patient Global Assessment
Time Frame
6 hours post study drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Singla, DO
Organizational Affiliation
Lotus Clinical Research, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lotus Clinical Research, LLC
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Methodological Validation of Ibuprofen Verses Placebo for Post Operative Pain After Third Molar Extraction Surgery
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