Ibuprofen Extended-Release Dental Pain Study

Condition(s) targeted: Pain; Post-Operative Pain; Third Molar Extraction

Intervention: Ibuprofen 600 mg Extended-Release Tablets (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: SCOLR Pharma, Inc.

Official(s) and/or principal investigator(s):
Steven E Christensen, D.D.S., Principal Investigator, Affiliation: Jean Brown Research

Overall contact:
Adriana Bulinaru, M.D., Phone: 1-877-816-9442, Ext: 292, Email: adriana.bulinaru@aaipharma.com

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.

Official title: Ibuprofen 600 mg Extended-Release (ER) Multiple-Dose Dental Pain Study

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Analgesic efficacy for the 8-12 hour dosing interval after Dose 1 using SPID.

Durability of effect as measured by the proportion of subjects in the Ibuprofen ER group achieving meaningful improvement in PID from baseline at all three assessment periods of 24, 36, and 48 hours.

Secondary outcome:

Time to confirmed "first perceptible" relief.

Time to confirmed "meaningful" relief.

Proportion of subjects in the Ibuprofen ER group with "first perceptible" relief within 1 hour of Dose 1.

Proportion of subjects in the Ibuprofen ER group achieving "meaningful" relief.

Analgesic efficacy for the 0-12, 0-4, 4-8, and 4-12 hour dosing intervals after Dose 1 using TOTPAR and SPID.

Duration of relief after Dose 1.

Proportion of subjects who are rescued at or prior to hour 8, hour 10, and hour 12 after taking Dose 1

Pain relief and PID scores at individual time points for Dose 1.

Global evaluation for Dose 1.

Global evaluation, maximum relief, and overall relief for Dose 2.

Global evaluation. maximum relief, and overall relief for Dose 3.

Global evaluation, maximum relief, and overall relief for Dose 4.

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 numerical rating and gender.

Minimum age: 16 Years. Maximum age: 45 Years. Gender(s): Both.

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 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.

Adriana Bulinaru, M.D., Phone: 1-877-816-9442, Ext: 292, Email: adriana.bulinaru@aaipharma.com

Jean Brown Research, Salt Lake City, Utah 84124, United States; Recruiting
Steven E Christensen, DDS
Steven E Christensen, DDS, Principal Investigator

Starting date: June 2008
Ending date: November 2008
Last updated: June 26, 2008