Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain

NCT00913627

Last updated date
Study Location
Jean Brown Research Center
Salt Lake City, Utah, 84124, United States
Contact
1-800-718-1021

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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

INCLUSION CRITERIA:

- Males and females 16 to 40 years of age.

- Outpatients who undergo surgical extraction of 1-2 third molars, one of which must be a partial or full bony mandibular impaction and have moderate to severe post-operative pain (confirmed by a VAS score of at least 50 mm on a 100 mm VAS) following surgical extraction;

- Use of only the following preoperative medication(s)/anesthetic(s): short-acting local anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor, nitrous oxide, and/or midazolam;

- Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form;

- Examined by the attending dentist or physician and medically cleared to participate in the study;

- In general good health and have no contraindications to the study medication.

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


EXCLUSION CRITERIA:


- Pregnancy, as verified by a urine-based pregnancy test, or breast feeding;


- Presence of a serious medical condition (e.g., poorly controlled hypertension, poorly
controlled diabetes, significantly impaired cardiac, renal or hepatic function,
poorly-controlled hyper- or hypothyroidism);


- Use of a prescription or nonprescription drug with which the administration of
ibuprofen or any other NSAID is contraindicated;


- Use of a bisphosphonate (e.g., risedronate [Actonel], alendronate [Fosamax], or
ibandronate [Boniva]) in the past 5-years;


- Acute localized dentalveolar infection at the time of surgery that could confound the
post-surgical evaluation;


- Females who are of child-bearing potential, or post-menopausal for less than 2 years
and not using a medically approved method of contraception (i.e., oral, transdermal,
or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or
surgical sterility), or females who test positive on a urine-based pregnancy test;


- Presence or history (within 2 years of enrollment) of bleeding disorder(s) or peptic
ulcer disease;


- History of alcoholism (i.e., on average, consumes 3 or more alcoholic drinks per day)
or substance abuse within the last year, or is currently abusing alcohol or other
mood-altering drugs (e.g., cannabis). Patients who are taking CNS or other
psychotropic drugs (including St. John's Wort, or any other nutritional supplement
known to have psychotropic effects) may be enrolled if they have been on stable doses
of medication for at least 2 months, will maintain this dose throughout the study, and
their condition is judged by the Principal Investigator to be well-controlled;


- Habituation to analgesic drugs (i.e., routine use of oral analgesics 5 or more times
per week)


- History of allergic reaction (e.g., asthma, rhinitis, swelling, shock, or hives) to
ibuprofen, naproxen, aspirin, or to any other NSAID; or to codeine, hydrocodone, or
acetaminophen, or to their combinations;


- Prior use of any type of analgesic or NSAID five half-lives of that drug or less
before taking the first dose of study medication, except for pre-anesthetic medication
and anesthesia for the procedure;


- Ingestion of any caffeine-containing beverages, chocolate, or alcohol 4 hours or less
before taking the first dose of study medication;


- The subject has taken an investigational product or participated in an investigational
trial within 30 days of study enrollment;


- The subject has previously participated in this study;


- The subject is a member of the study site staff directly involved with the study, an
employee of the Sponsor, or a relative of study site personnel directly involved with
the study.

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Ibuprofen 600 mg Extended Release (ER) For Dental Pain
Official Title  ICMJE Ibuprofen 600 Mg Extended Release (er) Single-dose Dental Pain Study
Brief Summary The purpose of this study is to assess the efficacy and safety of a single dose of an ibuprofen 600 mg extended release formulation in post-operative dental pain. There is concern that the manufacturing process may affect the performance characteristics of the selected prototype. Therefore, two formulations of this prototype manufactured by two different processes, [roller compaction] and [wet granulation] will be included in this study. The preferred prototype manufactured by two different methods will be compared to placebo and each other. This study will also characterize the pharmacokinetic/pharmacodynamic relationship with these formulations.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: ibuprofen
  • Drug: naproxen
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: 1
    1 x 600 mg ibuprofen IR/ER-roller compaction caplet
    Intervention: Drug: ibuprofen
  • Experimental: 2
    1 x 600 mg ibuprofen IR/ER-Wet granulation caplet
    Intervention: Drug: ibuprofen
  • Active Comparator: 3
    1x 220 mg naproxen sodium (Aleve caplet)
    Intervention: Drug: naproxen
  • Placebo Comparator: 4
    1 x placebo caplet
    Intervention: Drug: Placebo
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
 (submitted: August 12, 2009)
196
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2009)
210
Actual Study Completion Date  ICMJE August 5, 2009
Actual Primary Completion Date August 1, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

INCLUSION CRITERIA:

  • Males and females 16 to 40 years of age.
  • Outpatients who undergo surgical extraction of 1-2 third molars, one of which must be a partial or full bony mandibular impaction and have moderate to severe post-operative pain (confirmed by a VAS score of at least 50 mm on a 100 mm VAS) following surgical extraction;
  • Use of only the following preoperative medication(s)/anesthetic(s): short-acting local anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor, nitrous oxide, and/or midazolam;
  • Reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form;
  • Examined by the attending dentist or physician and medically cleared to participate in the study;
  • In general good health and have no contraindications to the study medication.

Exclusion Criteria:

EXCLUSION CRITERIA:

  • Pregnancy, as verified by a urine-based pregnancy test, or breast feeding;
  • Presence of a serious medical condition (e.g., poorly controlled hypertension, poorly controlled diabetes, significantly impaired cardiac, renal or hepatic function, poorly-controlled hyper- or hypothyroidism);
  • Use of a prescription or nonprescription drug with which the administration of ibuprofen or any other NSAID is contraindicated;
  • Use of a bisphosphonate (e.g., risedronate [Actonel], alendronate [Fosamax], or ibandronate [Boniva]) in the past 5-years;
  • Acute localized dentalveolar infection at the time of surgery that could confound the post-surgical evaluation;
  • Females who are of child-bearing potential, or post-menopausal for less than 2 years and not using a medically approved method of contraception (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility), or females who test positive on a urine-based pregnancy test;
  • Presence or history (within 2 years of enrollment) of bleeding disorder(s) or peptic ulcer disease;
  • History of alcoholism (i.e., on average, consumes 3 or more alcoholic drinks per day) or substance abuse within the last year, or is currently abusing alcohol or other mood-altering drugs (e.g., cannabis). Patients who are taking CNS or other psychotropic drugs (including St. John's Wort, or any other nutritional supplement known to have psychotropic effects) may be enrolled if they have been on stable doses of medication for at least 2 months, will maintain this dose throughout the study, and their condition is judged by the Principal Investigator to be well-controlled;
  • Habituation to analgesic drugs (i.e., routine use of oral analgesics 5 or more times per week)
  • History of allergic reaction (e.g., asthma, rhinitis, swelling, shock, or hives) to ibuprofen, naproxen, aspirin, or to any other NSAID; or to codeine, hydrocodone, or acetaminophen, or to their combinations;
  • Prior use of any type of analgesic or NSAID five half-lives of that drug or less before taking the first dose of study medication, except for pre-anesthetic medication and anesthesia for the procedure;
  • Ingestion of any caffeine-containing beverages, chocolate, or alcohol 4 hours or less before taking the first dose of study medication;
  • The subject has taken an investigational product or participated in an investigational trial within 30 days of study enrollment;
  • The subject has previously participated in this study;
  • The subject is a member of the study site staff directly involved with the study, an employee of the Sponsor, or a relative of study site personnel directly involved with the study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 NCT00913627
Other Study ID Numbers  ICMJE AK-09-07
B4371001 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP