A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine
NCT02863575
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
Adult Trials: 18+ Years
- Males and females 16 years to 40 years of age (inclusive).
- Subjects who have undergone outpatient surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction within 30 days of Screening and have met baseline pain criteria as described in this protocol
- Examined by the attending dentist or physician and medically cleared to participate in the study.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
metabolic or allergic disease (including drug allergies, but excluding untreated,
asymptomatic, seasonal allergies at the time of dosing) determined by the Investigator
to place the subject at increased risk including the presence or history within 2
years of screening of the following medical conditions/disorders:
- Bleeding disorder;
- Gastrointestinal ulcer or gastrointestinal bleeding;
- Paralytic ileus or other gastrointestinal obstructive disorders.
- Pregnant female subjects; breastfeeding female subjects; fertile male subjects and
female subjects of childbearing potential who are unwilling or unable to use a highly
effective method of contraception
- Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID, caffeine, or
other component of the product.
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine | ||||||
| Official Title ICMJE | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY COMPARING THE ANALGESIC EFFICACY AND SAFETY OF A SINGLE ORAL DOSE OF A NOVEL FIXED-DOSE COMBINATION OF IBUPROFEN 400 MG WITH CAFFEINE 100 MG TO IBUPROFEN 400 MG AND TO PLACEBO IN THE TREATMENT OF POST-SURGICAL DENTAL PAIN IN OTHERWISE HEALTHY SUBJECTS | ||||||
| Brief Summary | An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental pain. | ||||||
| Detailed Description | The purpose of this study is to assess the analgesic efficacy of a fixed dose combination of ibuprofen/caffeine compared to ibuprofen alone and also to placebo. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
| Condition ICMJE | Pain | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 374 | ||||||
| Original Estimated Enrollment ICMJE | 385 | ||||||
| Actual Study Completion Date ICMJE | April 6, 2018 | ||||||
| Actual Primary Completion Date | April 6, 2018 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 16 Years to 40 Years (Child, Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT02863575 | ||||||
| Other Study ID Numbers ICMJE | B3741002 MIG ( Other Identifier: Alias Study Number ) MIG II ( Other Identifier: Alias Study Number ) | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||||
| Verification Date | April 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||