Dental Pain Clinical Trial
Official title:
Methodological Validation of Ibuprofen Verses Placebo for Post Operative Pain After Third Molar Extraction Surgery
Verified date | April 2015 |
Source | Lotus Clinical Research, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This is a single center placebo controlled, prospective, randomized study on healthy adults undergoing third molar surgery.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
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 (ß-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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Lotus Clinical Research, LLC | Pasadena | California |
Lead Sponsor | Collaborator |
---|---|
Lotus Clinical Research, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Total Pain Relief (TOTPAR) 6 | 6 hours | No | |
Other | Patient Global Assessment | 6 hours post study drug administration | No | |
Primary | Sum of pain intensity difference (SPID)6 | 6 hours | No | |
Secondary | Sum of pain intensity difference (SPID) 3 | 3 hour | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00942448 -
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery
|
Phase 3 | |
Completed |
NCT00985439 -
Study of Diclofenac Capsules to Treat Dental Pain
|
Phase 2 | |
Completed |
NCT00954356 -
Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction
|
Phase 2 | |
Completed |
NCT00943098 -
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery
|
Phase 3 | |
Completed |
NCT02966067 -
A Split Mouth Trial to Compare Microneedles vs. Standard Needles in Dental Anaesthetic Delivery
|
N/A | |
Completed |
NCT01960114 -
Study of Long-Acting Acetaminophen in Postoperative Dental Pain
|
Phase 2 | |
Completed |
NCT01229228 -
Study of Naproxen Capsules to Treat Dental Pain
|
Phase 2 | |
Completed |
NCT01177423 -
Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block
|
N/A | |
Completed |
NCT03328208 -
Nonpharmacologic Reduction of Periprocedural Distress and Drug Use
|
N/A | |
Completed |
NCT05236101 -
Validation of Child Drawing Hospital Scale (CD: H) and the Place of the Drawing in the Evaluation of Dental Anxiety
|
N/A | |
Completed |
NCT00542035 -
A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
|
Phase 2 | |
Completed |
NCT04231955 -
Comparison of Different Pain Rating Scales in Patients With Symptomatic Teeth
|
N/A | |
Completed |
NCT05369936 -
Pain Perception: on Relationships Between Dental Anxiety and Olfaction
|
N/A | |
Recruiting |
NCT05351099 -
Dental Block for Pain Relief in ED Dental Pain Patients
|
||
Not yet recruiting |
NCT06269406 -
A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults
|
N/A | |
Recruiting |
NCT05443009 -
Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction
|
Phase 4 | |
Terminated |
NCT02161354 -
Safety and Efficacy Study of NTC-510 to Treat Pain Following Dental Surgery of Third Molars
|
Phase 2 | |
Completed |
NCT04949126 -
Self Medication in Odontology (AUDE)
|
||
Completed |
NCT03652818 -
Dental Pain Study of Analgesics in Patients Undergoing Molar Removal
|
Phase 2 | |
Withdrawn |
NCT05194449 -
Nonpharmacologic Reduction of Periprocedural Pain and Anxiety in Dentistry
|
N/A |