Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain

NCT01216163 | Completed Phase 3 Results

• 2 other identifiers: AH-09-14B3411002
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the analgesic efficacy of a single-dose of a novel ibuprofen formulation to placebo and acetaminophen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.

Conditions

Pain

Keywords

Pain following third molar extraction (wisdom tooth)

Outcome Measures

Primary Outcomes (2)

• Time-weighted Sum of Pain Relief Rating With Pain Intensity Difference From 0 to 6 Hours (SPRID 0-6)

  SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 6 hours. Score range: -6(worst) to 42(best) for SPRID 0-6. PRID: sum of pain intensity difference (PID) and pain relief rating (PRR) at each time point. Score range for PRID: -1(worst) to 7(best). PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). Total score range for PID: -1 (worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).

  0 to 6 hours

• Time to Onset of Meaningful Relief

  Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 6 hours after dosing or until stopped by the participant, or rescue medication was administered.

  0 to 6 hours

Secondary Outcomes (13)

• Time to Confirmed First Perceptible Relief

  0 to 6 hours

• Pain Relief Rating (PRR)

  0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours

• Pain Intensity Difference (PID)

  0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours

• Sum of Pain Relief Rating and Pain Intensity Difference (PRID)

  0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6 hours

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

  0 to 2, 0 to 3, 0 to 6 hours

Study Arms (3)

Treatment A

EXPERIMENTAL

Drug: Novel Ibuprofen

Treatment B

ACTIVE COMPARATOR

Drug: Acetaminophen

Treatment C

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Novel Ibuprofen DRUG

Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)

Treatment A

Acetaminophen DRUG

Single-dose of acetaminophen (1000mg)

Treatment B

Placebo DRUG

Single-dose of placebo

Treatment C

Eligibility Criteria

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

You may qualify if:

• Normal, healthy males and females 16 to 40 years of age
• Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating \[VAS-PSR\] score of at least 50 mm on a 100 mm VAS PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
• Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide

You may not qualify if:

• Pregnancy or breast-feeding
• Alcohol or substance abuse
• Any serious medical or psychiatric disorder
• History of stomach ulcers, stomach bleed, or other bleeding disorders
• Use of a prescription or over-the-counter (OTC) drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug (NSAID); acetaminophen (APAP); or codeine or any other opioid is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants \[including alcohol\])

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

• Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.

  PMID: 25526232 DERIVED

Related Links

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

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 7, 2010
• Study Start: October 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: August 20, 2012
• Results First Posted: August 20, 2012

Record last verified: 2012-07

Locations

US (1)