Clinical trial NCT00707057: Ibuprofen Extended-Release Dental Pain Study
Official title: Ibuprofen 600 mg Extended-Release (ER) Multiple-Dose Dental Pain Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Post-Operative Pain
Third Molar Extraction
Lead sponsor: SCOLR Pharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: AAIPharma
name: Jean Brown Research
First posted: 2008-06-30
Enrollment: 256
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth.

Detailed description: This is a single-center, multiple-dose, randomized, placebo-controlled, double-blinded, parallel group trial to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth. The surgery will consist of surgical extraction of 1-2 impacted third molars, of which one must be a mandibular impaction that is partially impacted in either tissue or bone. Subjects will be stratified according to baseline pain intensity, as rated on an 11-point pain intensity numerical rating scale (PI-NRS)and gender.

Eligibility criteria: Inclusion Criteria:

* Males and females 16 to 45 years of age;
* Outpatients scheduled to undergo surgical extraction of 1-2 impacted third molar(s), one of which must be a mandibular impaction that is partially impacted in either tissue or bone;
* At least a score of 5 on the 11-point pain intensity numerical rating scale (PI-NRS) at baseline;
* Use of only the following preoperative medication(s) / anesthetic(s): short-acting local anesthetic (e.g., mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide;
* Reliable, cooperative, and adequate intelligence to record the requested information on the analgesic questionnaire form;
* Subjects (or the parent or legal guardian of subjects under the age of 18 years) are required to read, comprehend, and sign the informed consent. Subjects requiring a parent or legal guardian to sign the informed consent will be required to sign an assent;
* Examined by the attending dentist or physician and medically cleared to participate in the study; and,
* In general good health and have no contraindications to any of the study meds.

Exclusion Criteria:

* Presence of a serious medical condition (e.g., poorly controlled hypertension, poorly controlled diabetes, significantly impaired cardiac, renal or hepatic function, hyper- or hypothyroidism);
* Use of a prescription or nonprescription drug with which the administration of ibuprofen, celecoxib, any other non-steroidal anti-inflammatory drug (NSAID), or acetaminophen, is contraindicated;
* Acute local infection at the time of surgery that could confound the post-surgical evaluation;
* Females who are pregnant, lactating, of child-bearing potential, or postmenopausal 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;
* Presence or history (within the past year) of alcoholism or substance abuse. Subjects 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 (eg, asthma, rhinitis, swelling, shock, or hives) to ibuprofen, naproxen, aspirin, celecoxib, any other NSAID, or acetaminophen;
* Prior use of any type of analgesic or NSAID 5 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;
* Has taken an investigational product within the past 30 days;
* Has previously been entered into this study; and,
* The subject is a member of the study site staff either directly involved with the study, an employee of the Sponsor, or a relative of study site personnel directly involved with the study or Sponsor.

Primary outcomes:
measure: Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale
timeFrame: from baseline to 12 hours after dose 1
measure: Durability of Effect as Measured by the Number of Subjects Achieving Meaningful Improvement in Pain Intensity Difference (PID) From Baseline at All Three Assessment Periods of 24, 36, and 48 Hours
timeFrame: 24, 36, and 48 hours
Secondary outcomes:
measure: Time to Confirmed "First Perceptible" Relief
timeFrame: Within 4 hours post Dose 1
measure: Time to Confirmed "Meaningful" Relief
timeFrame: Within 4 hours post Dose 1
measure: Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1
timeFrame: Within 1 hour of Dose 1
measure: Percentage of Subjects Achieving "Meaningful" Relief as Indicated by the Time Recorded on the Second Stopwatch Following "First Perceptible" Relief
timeFrame: Within 4 hours post Dose 1
measure: Analgesic Efficacy for the 0-12, 0-4, 4-8, and 4-12 Hour Dosing Intervals After Dose 1 Using Total Pain Relief (TOTPAR) and Sum of Pain Intensity Difference(SPID)
timeFrame: 0-12 hours after Dose 1
measure: Duration of Relief After Dose 1
timeFrame: Time to rescue or time of Dose 2 (up to 12 hours following dose 1)
measure: Percentage of Participants Who Require Rescue Medication at or Prior to Hour 8, Hour 10, and Hour 12 After Taking Dose 1
timeFrame: 0-12 hours after taking Dose 1
measure: Pain Relief and PID Scores at Individual Time Points for Dose 1
timeFrame: 24, 36, 48 hours after taking Dose 1
measure: Global Evaluation for Dose 1
timeFrame: At 12 hours after Dose 1 or at time of rescue
measure: Global Evaluation, Maximum Relief, and Overall Relief for Dose 2
timeFrame: At 24 hours or at time of rescue between 12 and 24 hours
measure: Global Evaluation, Maximum Relief, and Overall Relief for Dose 3
timeFrame: At 36 hours or at time rescue between 24 and 36 hours
measure: Global Evaluation, Maximum Relief, and Overall Relief for Dose 4
timeFrame: At 48 hours or at time of rescue between 36 and 48 hours.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Jean Brown Research
name: Steven E Christensen, D.D.S.
role: PRINCIPAL_INVESTIGATOR
References: