Multiple Dose Dental Pain Study Of Ibuprofen Extended Release

NCT01266161 | Completed Phase 3 Results

• 2 other identifiers: B3491001AK-10-13
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief Summary

The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.

Conditions

Pain

Keywords

dental pain; multiple dose; ibuprofen; third molar extraction

Outcome Measures

Primary Outcomes (2)

• Time-weighted Sum of Pain Relief and Pain Intensity Difference Scores From 0 to 12 Hours After the First Dose (SPRID 0-12)

  SPRID is time-weighted sum of pain relief (PR) plus pain intensity (PI) difference (PID) (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0 equals \[=\] none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for PI: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement in pain intensity. SPRID 0-12 score ranged from -12 to 84; higher score indicated better efficacy.

  Baseline to 12 hours

• Sum of Pain Relief and Pain Intensity Difference Scores From 8-12 Hours After the First Dose

  SPRID is time-weighted sum of PR plus PID (PRID) scores. 5-point categorical scale for PR: "How much relief do you have from your starting pain?" (0=none, 1=a little, 2=some, 3=a lot, 4=complete). 4-point categorical scale for pain intensity: "How much pain do you have at this time?" (0=none, 1=mild, 2=moderate, 3=severe). PID score=baseline pain intensity score minus pain intensity at each time point; score ranged from -1 to 3; higher positive PID value indicated improvement (decrease) in pain intensity. SPRID 8-12 score ranged from -4 to 28; higher score indicated better efficacy.

  8 to 12 hours

Secondary Outcomes (11)

• Time-weighted Sum of Pain Intensity Difference (SPID) Scores

  0 to 12 hours, 8 to 12 hours, 12 to 24 hours, 20 to 24 hours, 0 to 24 hours, 24 to 36 hours, 32 to 36 hours, 36 to 48 hours, 44 to 48 hours, 24 to 48 hours

• Time to First Dose of Rescue Medication After First Dose of Study Drug

  Baseline to 12 hours

• Percentage of Participants Taking Rescue Medication

  Baseline to 48 hours

• Pain Relief (PR) Scores

  0.5, 1, 1.5, 2, 4, 6, 8, 10, 12 hours

• Pain Intensity Difference (PID) Scores

  0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 hours

Study Arms (2)

Ibuprofen 600 mg extended release

EXPERIMENTAL

Drug: Ibuprofen 600 mg ER

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Ibuprofen 600 mg ER DRUG

One 600 mg caplet dosed at 0, 12, 24 and 36 hours

Ibuprofen 600 mg extended release

Placebo DRUG

One placebo caplet dosed at times 0, 12, 24 and 36 hours

Placebo

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males and females 16 to 40 years of age
• Subjects who undergo surgical removal of at least two third molars
• One of which must be a partial or full bony mandibular impaction
• Subjects must have at least moderate baseline pain (a score of 2 on the categorical pain severity rating scale) confirmed by a score of at least 50 mm on the 100-mm visual analog scale-pain severity rating scale (VAS-PSR)

You may not qualify if:

• Acute localized dental infection at the time of surgery that could confound the post-surgical evaluation
• Presence or history of any significant organ disease
• Use of prescription or OTC first generation antihistamines
• Females who are pregnant, lactating or of childbearing potential and not using a medically approved method to prevent pregnancy

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Central Texas Oral Surgery Associates

Austin, Texas, 78705, United States

Location

Premier Research

Austin, Texas, 78705, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pain; Toothache

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Tooth Diseases; Stomatognathic Diseases; Facial Pain

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2010
• First Posted: December 24, 2010
• Study Start: November 22, 2010
• Primary Completion: March 31, 2011
• Study Completion: March 31, 2011
• Last Updated: August 15, 2018
• Results First Posted: August 15, 2018

Record last verified: 2018-08

Locations

US (2)