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A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine

Last updated on April 12, 2018

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Study Location
Jean Brown Research
Salt Lake City, Utah, 84124 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-40 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT02863575
Pfizer
Recruiting
A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine

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A Dental Pain Study Comparing The Analgesic Efficacy Of Ibuprofen/Caffeine
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
An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental pain.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: Ibuprofen/Caffeine
    Ibuprofen/Caffeine fixed-dose combination
  • Drug: Ibuprofen
    Ibuprofen capsule
  • Drug: Placebo
    Placebo treatment
  • Experimental: Ibuprofen/Caffeine
    Ibuprofen 400 mg/ Caffeine 100 mg fixed-dose combination
    Intervention: Drug: Ibuprofen/Caffeine
  • Active Comparator: Ibuprofen
    Ibuprofen 400 mg
    Intervention: Drug: Ibuprofen
  • Placebo Comparator: Placebo
    Placebo comparator
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
385
May 25, 2018
May 25, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
16 Years to 40 Years   (Child, Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT02863575
B3741002
MIG ( Other Identifier: Alias Study Number )
MIG II ( Other Identifier: Alias Study Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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