A Safety And Efficacy Study of Ibuprofen 250 mg / Acetaminophen 500 mg In The Treatment Of Post-Surgical Dental Pain

NCT02912650 | Completed Phase 3 Results

• 2 other identifiers: B5061003GEMINI SDDP
• Study Type: interventional
• Target: 568
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double blind, placebo-controlled, parallel group, single-center study in approximately 560 subjects to determine the overall analgesic efficacy and safety of a fixed-dose ibuprofen 250 mg / acetaminophen 500 mg formulation compared to ibuprofen 250 mg alone, acetaminophen 650 mg alone, and to placebo. Subjects will be healthy males and females aged 18-40 years, inclusive, who are experiencing post-operative pain following surgical extraction of 3 or more third molar teeth. Following extraction, subjects must experience, within 5 hours, post-surgical pain of at least moderate severity (on a 4-point categorical scale), confirmed by a Visual Analog Pain Severity Rating Scale (VAS PSR) of at least 50 mm on a 100 mm VAS PSR scale. Eligible subjects will be randomized to receive a single oral dose of study medication under double-blind conditions and then evaluated on site for 12 hours following administration of study medication. Subjects will provide self-ratings of pain severity and pain relief at various time points using categorical and numerical scales. Additionally, subjects will also evaluate the time to first perceptible relief and time to meaningful relief using a double stopwatch method. Finally, at 12 hours, subjects will complete a categorical Global Evaluation of the study medication. A review of any reported adverse events will also be completed.

Conditions

Post-surgical Pain Following Extraction of Molar Teeth

Keywords

ibuprofen; acetaminophen; pain; molar extraction

Outcome Measures

Primary Outcomes (1)

• Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 0 to 8 Hours Post-dose (SPID11 [0-8])

  Pain intensity was assessed on an 11-point numerical pain severity rating scale. SPID11 (0-8): Time-weighted sum of pain intensity difference (PID) scores over 8 hours. SPID11 score range was -40 (worst score) to 80 (best score) for SPID 0-8. PID was calculated by subtracting the pain intensity score at given post-dose time points (pain severity score range: 0 =no pain to 10 =worst possible pain) from the baseline pain intensity scores (score range: 5 =moderate pain to 10 =worst possible pain; as participants with baseline pain score of at least moderate were included in study). Total possible score range for PID: -5 (worst score) to 10 (best score).

  0 to 8 hours post-dose

Secondary Outcomes (5)

• Time-weighted Sum of Pain Intensity Difference Scores on 11-Point Numerical Scale From 6 to 8 Hours Post-dose (SPID11 [6-8])

  6 to 8 hours post-dose

• Time-weighted Sum of Pain Relief Rating (TOTPAR) From 0 to 8 Hours and 6 to 8 Hours Post-dose

  0 to 8 hours, 6 to 8 hours post-dose

• Time to Treatment Failure

  0 to 12 hours post-dose

• Cumulative Percentage of Participants With Treatment Failure at 6 and 8 Hours

  6 hours, 8 hours post-dose

• Time to Onset of Meaningful Pain Relief

  0 to 12 hours post-dose

Other Outcomes (13)

• Time to Confirmed Onset of First Perceptible Relief

  0 to 12 hours post-dose

• Pain Relief Rating (PRR) Score

  0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

• Pain Intensity Difference on 11-Point Numerical Scale (PID11)

  0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 hours post-dose

Study Arms (4)

Ibuprofen 250 mg / Acetaminophen 500 mg

EXPERIMENTAL

2 caplets of Ibuprofen 125 mg / Acetaminophen 250 mg

Drug: Ibuprofen 250 mg / Acetaminophen 500 mg

Ibuprofen 250 mg

ACTIVE COMPARATOR

2 caplets of IBU 125 mg

Drug: Ibuprofen 250 mg

Acetaminophen 650 mg

ACTIVE COMPARATOR

2 tablets of APAP 325 mg

Drug: Acetaminophen 650 mg

Placebo

ACTIVE COMPARATOR

2 caplets of Placebo

Drug: Placebo

Interventions

Ibuprofen 250 mg / Acetaminophen 500 mg DRUG

2 caplets of Ibuprofen 250 mg / Acetaminophen 500 mg

Also known as: IBU 250 / APAP 500

Ibuprofen 250 mg / Acetaminophen 500 mg

Ibuprofen 250 mg DRUG

2 caplets of Ibuprofen 125 mg

Also known as: IBU 250

Ibuprofen 250 mg

Acetaminophen 650 mg DRUG

2 tablets of Acetaminophen 325 mg

Also known as: APAP 650

Acetaminophen 650 mg

Placebo DRUG

2 caplets of Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Outpatients who have undergone surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction.
• Subject must have at least moderate pain on the 4-point categorical scale, confirmed by at least 50 mm on the 100 mm VAS PSR scale within approximately 5 hours (i.e., less than or equal to 5 hours, 15 minutes) after surgery is completed.
• Female subjects are not pregnant or breast feeding.
• Informed consent.

You may not qualify if:

• Presence or history of any significant hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorder determined by the Investigator to place the subject at increased risk, including the presence or history within 2 years of screening.
• Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation.
• Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID; or to APAP, tramadol, other opioids, or to their combinations.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Related Links

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

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; 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: January 7, 2016
• First Posted: September 23, 2016
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 30, 2017
• Results First Posted: August 30, 2017

Record last verified: 2017-07

Locations

US (1)