Ibuprofen Extended-Release Dental Pain Study

NCT00707057 | Completed Phase 3 Results

• 1 other identifier: SCO-0001
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Post-Operative Pain; Third Molar Extraction

Outcome Measures

Primary Outcomes (2)

• Analgesic Efficacy, as Measured by the Sum of Pain Intensity Differences (SPID) Scale

  Analgesic efficacy for the 8-12 hour measurement interval after dose 1 using Sum of Pain Intensity Differences (SPID). An 11-point Pain Intensity Numerical Rating Scale (PI-NRS) was used to record pain intensity at baseline and 8, 9, 10, 11, 12 hours after dose 1. The scale went from 0 (no pain) to 10 (Worst possible pain). The outcome measure is based a mean of the sum of each of the five time points evaluated. The total time scale ranges from 0 to 50. Subjects were asked to select the number that best describes how much pain they had at the time of observation.

  from baseline to 12 hours after dose 1

• 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

  Response rate measured the durability of effect and was measured by the number of subjects achieving a reduction of at least 2 points (greater than or equal to 20%) from baseline on the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at all 3 assessment periods of 24, 36 and 48 hours. The scale went from 0 (no pain) to 10 (Worst possible pain). Subjects were asked to select the number that best describes how much pain they had at the time of observation.

  24, 36, and 48 hours

Secondary Outcomes (12)

• Time to Confirmed "First Perceptible" Relief

  Within 4 hours post Dose 1

• Time to Confirmed "Meaningful" Relief

  Within 4 hours post Dose 1

• Percentage (%) of Subjects With Confirmed First Perceptible Relief Within 1 Hour of Dose 1

  Within 1 hour of Dose 1

• Percentage of Subjects Achieving "Meaningful" Relief as Indicated by the Time Recorded on the Second Stopwatch Following "First Perceptible" Relief

  Within 4 hours post Dose 1

• 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)

  0-12 hours after Dose 1

Study Arms (2)

Ibuprofen 600 mg ER group

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, as rated on an 11-point numerical rating scale (PI-NRS; 5-7 moderate pain, or 8-10, severe pain).

Drug: Ibuprofen 600 mg Extended-Release Tablets

Placebo group

PLACEBO COMPARATOR

Eighty subjects will be randomly assigned to the Placebo treatment group based on gender and baseline pain intensity, as rated on an 11-point numerical rating scale (PI-NRS; 5-7 moderate pain, or 8-10, severe pain).

Drug: Placebo

Interventions

Ibuprofen 600 mg Extended-Release Tablets DRUG

Ibuprofen 600 mg Extended-Release Tablet: One 600 mg tablet taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.

Also known as: Ibuprofen 600 mg ER

Ibuprofen 600 mg ER group

Placebo DRUG

Placebo: One matching placebo tablet was taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.

Placebo group

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SCOLR Pharma, Inc.: lead
• AAIPharma: collaborator
• Jean Brown Research: collaborator

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

Of the 12 subjects who prematurely discontinued all 4 doses of the study drug, 6 subjects received 1 dose of study drug, 2 subjects received 2 doses, and 4 subjects received 3 doses.

Results Point of Contact

• Title: Stephen Turner, VP and Chief Technical Officer
• Organization: SCOLR Pharma Inc

sturner@scolr.com

425-368-1050

Study Officials

• Steven E Christensen, D.D.S.

  Jean Brown Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 26, 2008
• First Posted: June 30, 2008
• Study Start: June 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: March 24, 2011
• Results First Posted: March 23, 2011

Record last verified: 2011-03

Locations

US (1)