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Ibuprofen Extended-Release Dental Pain Study
This study has been completed.
First Received: June 26, 2008   Last Updated: October 31, 2008   History of Changes
Sponsor: SCOLR Pharma, Inc.
Collaborators: AAIPharma
Jean Brown Research
Information provided by: SCOLR Pharma, Inc.
ClinicalTrials.gov Identifier: NCT00707057
  Purpose

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.


Condition Intervention Phase
Pain
Post-Operative Pain
Third Molar Extraction
Drug: Ibuprofen 600 mg Extended-Release Tablets
Drug: Placebo
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Ibuprofen 600 mg Extended-Release (ER) Multiple-Dose Dental Pain Study

Resource links provided by NLM:


Further study details as provided by SCOLR Pharma, Inc.:

Primary Outcome Measures:
  • Analgesic efficacy for the 8-12 hour dosing interval after Dose 1 using SPID. [ Time Frame: 8 - 12 hours ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 24, 36, and 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to confirmed "first perceptible" relief. [ Time Frame: Within 4 hours post Dose 1 ] [ Designated as safety issue: No ]
  • Time to confirmed "meaningful" relief. [ Time Frame: Within 12 hours post Dose 1 ] [ Designated as safety issue: No ]
  • Proportion of subjects in the Ibuprofen ER group with "first perceptible" relief within 1 hour of Dose 1. [ Time Frame: Within 1 hour of Dose 1 ] [ Designated as safety issue: No ]
  • Proportion of subjects in the Ibuprofen ER group achieving "meaningful" relief. [ Time Frame: Within 12 hours post Dose 1 ] [ Designated as safety issue: No ]
  • Analgesic efficacy for the 0-12, 0-4, 4-8, and 4-12 hour dosing intervals after Dose 1 using TOTPAR and SPID. [ Time Frame: 0-12 hours after Dose 1 ] [ Designated as safety issue: No ]
  • Duration of relief after Dose 1. [ Time Frame: Time to rescue or at time of Dose 2 ] [ Designated as safety issue: No ]
  • Proportion of subjects who are rescued at or prior to hour 8, hour 10, and hour 12 after taking Dose 1 [ Time Frame: 0-12 hours after taking Dose 1 ] [ Designated as safety issue: No ]
  • Pain relief and PID scores at individual time points for Dose 1. [ Time Frame: 0-12 hours after taking Dose 1 ] [ Designated as safety issue: No ]
  • Global evaluation for Dose 1. [ Time Frame: At 12 hours after Dose 1 or at time of rescue ] [ Designated as safety issue: No ]
  • Global evaluation, maximum relief, and overall relief for Dose 2. [ Time Frame: At 24 hours or at time of rescue between 12 and 24 hours ] [ Designated as safety issue: No ]
  • Global evaluation. maximum relief, and overall relief for Dose 3. [ Time Frame: At 36 hours or at time rescue between 24 and 36 hours ] [ Designated as safety issue: No ]
  • Global evaluation, maximum relief, and overall relief for Dose 4. [ Time Frame: At 48 hours or at time of rescue between 36 and 48 hours. ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: June 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
One-hundred and sixty subjects will be randomly assigned to the Ibuprofen 600 mg ER treatment group based on gender and baseline pain intensity rating.
Drug: Ibuprofen 600 mg Extended-Release Tablets
Ibuprofen 600 mg Extended-Release Tablet: One 600 mg tablet given twice daily (BID)at times = 0,12,24, and 36 hours.
B: Placebo Comparator
Eighty subjects will be randomly assigned to the Placebo treatment group based on gender and baseline pain intensity rating.
Drug: Placebo
Placebo: One matching placebo tablet given twice daily (BID) at times = 0, 12, 24, and 36 hours.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00707057

Locations
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Sponsors and Collaborators
SCOLR Pharma, Inc.
AAIPharma
Jean Brown Research
Investigators
Principal Investigator: Steven E Christensen, D.D.S. Jean Brown Research
  More Information

No publications provided

Responsible Party: SCOLR Pharma, Inc. ( Tanya Raco, Associate VP of Regulatory Affairs )
Study ID Numbers: SCO-0001
Study First Received: June 26, 2008
Last Updated: October 31, 2008
ClinicalTrials.gov Identifier: NCT00707057     History of Changes
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Ibuprofen
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Postoperative Complications
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Pain, Postoperative

ClinicalTrials.gov processed this record on November 09, 2009