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

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: May 29, 2009
Last updated: November 9, 2012
Last verified: November 2012
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.

Condition Intervention Phase
Drug: ibuprofen
Drug: naproxen
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Ibuprofen 600 mg Extended Release (ER) Single-Dose Dental Pain Study

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • SPID 0-12 (time weighted sum of pain intensity difference scores from 0-12 hrs) AND SPID 8-12 (time-weighted sum of pain intensity difference scores from 8-12 hrs) [ Time Frame: 24-hours ]

Secondary Outcome Measures:
  • Time to first perceptible relief confirmed by meaningful relief (onset) AND Time to treatment failure (time to first rescue medication or discontinuation due to lack of efficacy) AND Percentage of treatment failures by 8, 9, 10, 11 and 12 hours [ Time Frame: 24-hours ]

Enrollment: 196
Study Start Date: May 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
1 x 600 mg ibuprofen IR/ER-roller compaction caplet
Drug: ibuprofen
Experimental: 2
1 x 600 mg ibuprofen IR/ER-Wet granulation caplet
Drug: ibuprofen
Active Comparator: 3
1x 220 mg naproxen sodium (Aleve caplet)
Drug: naproxen
Placebo Comparator: 4
1 x placebo caplet
Drug: Placebo


Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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.


  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00913627

United States, Utah
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

Responsible Party: Pfizer Identifier: NCT00913627     History of Changes
Other Study ID Numbers: AK-09-07
Study First Received: May 29, 2009
Last Updated: November 9, 2012

Keywords provided by Pfizer:
Extended-release, ibuprofen

Additional relevant MeSH terms:
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gout Suppressants processed this record on April 25, 2017