Efficacy Of PF-05089771 In Treating Postoperative Dental Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01529346
First received: December 13, 2011
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

The objective of this study is to evaluate the overall pain relief of a single dose of PF-05089771 against placebo following third molar extraction.


Condition Intervention Phase
Postoperative Dental Pain
Drug: PF-05089771
Other: Placebo
Drug: Ibuprofen
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Double-Dummy, Parallel Group, Placebo Controlled Study Assessing The Efficacy Of Single Doses Of PF-05089771 For The Treatment Of Postoperative Dental Pain Using Ibuprofen 400 mg As Positive Control

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Total Pain Relief over the period from 0- 6 hr post dose (TOTPAR 6). TOTPAR 6 is defined as the area under the PR curve through the first 6 hours post-dosing. [ Time Frame: 0-6 hr post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak Pain relief (PPR) [ Time Frame: 0-24 hr post dose ] [ Designated as safety issue: No ]
  • Time specific pain relief (PR) [ Time Frame: 0-24 hr post dose ] [ Designated as safety issue: No ]
  • Time-specific Pain Intensity Difference (PID) [ Time Frame: 0-24 hr post dose ] [ Designated as safety issue: No ]
  • Summed Pain Intensity Difference (SPID) [ Time Frame: 6 hr and 24 hr post dose ] [ Designated as safety issue: No ]
  • Total Pain Relief TOTPAR[24] (area under the PR curve through the first 24 hr post dose). [ Time Frame: 0-24 hr post dose ] [ Designated as safety issue: No ]
  • Time to perceptible pain relief (PR). At the time of dosing with study medication, 2 stopwatches will be started. Subjects will be instructed to stop the first stopwatch at the time they feel any pain relieving effect. [ Time Frame: 0-6 hr post dose. ] [ Designated as safety issue: No ]
  • Time to meaningful pain relief (PR). At the time of dosing with study medication, 2 stopwatches will be started. Subjects will be instructed to stop the second stopwatch when they feel the pain relief is meaningful to them. [ Time Frame: 0-6 hr post dose ] [ Designated as safety issue: No ]
  • Patient's Global Evaluation of Study Medication [ Time Frame: 6 hr and 24 hr post dose and immediately prior to rescue medication. ] [ Designated as safety issue: No ]
  • Patient Satisfaction Questionnaire [ Time Frame: 6 hr and 24 hr post dose and immediately prior to rescue medication. ] [ Designated as safety issue: No ]
  • Pharmacokinetic (PK) profile of PF-05089771 and ibuprofen [ Time Frame: Day 0 (pre-dose), 30 min, 60 min, 2 hr, 4 hr, 6 hr, 8 hr, 10 hr and 24 hr post dose ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Up to 28 days post dose. ] [ Designated as safety issue: Yes ]
  • Safety Lab tests [ Time Frame: Day -28 to Day 0;Day 0, Day 2, Day 7-10 ] [ Designated as safety issue: Yes ]
  • Blood pressure and pulse rate [ Time Frame: Day -28 to Day 0, Day 1, Day 2, Day 7-10 ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: Day -28 to Day0; 6 hr and 24 hr post dose, Day 7-10 if required ] [ Designated as safety issue: Yes ]

Enrollment: 235
Study Start Date: December 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-05089771 1600 mg Drug: PF-05089771
A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Experimental: PF-05089771 450 mg Drug: PF-05089771
A single dose of PF-05089771 450 mg oral solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Experimental: PF-05089771 150 mg Drug: PF-05089771
A single dose of PF-05089771 150 mg oral solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
Active Comparator: Ibuprofen 400 mg Drug: Ibuprofen
2 X 200 mg tablets of ibuprofen administered orally once to the subject on Day 1 postoperatively
Other: Placebo
Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Placebo Comparator: Placebo Other: Placebo
Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
Other: Placebo
Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Oral surgery having removed 2 unilateral third molar teeth.
  • Pre-dose pain intensity score (100 mm VAS [VAS]) of at least 50mm within 5 hours of oral surgery
  • Pre-dose pain intensity score of moderate or severe within 5 hours of oral surgery

Exclusion Criteria:

  • Presence or known history of any clinically significant hematological, hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, allergic (including known drug hypersensitivities or allergies, but excluding untreated asymptomatic seasonal allergy) or any metabolic disorder that may increase risk associated with study participation, investigational drug administration or may interfere with interpretation of study results.
  • Prior use of any type of analgesic or NSAID within 5-half lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure.
  • Active dental infection at the time of surgery.
  • Recent (within the previous 12 months) history of chronic analgesic or tranquiliser dependency.
  • Any significant oral surgery complication at the time of surgery or in the immediate postoperative period, or oral surgery that has lasted more than 30 minutes (time from first incision to last suture placement).

Subjects who smoke more than 1 pack (20 cigarettes) per day, more than 3 cigars per day or use smokeless tobacco on a daily basis are excluded from the study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01529346

Locations
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78744
Pfizer Investigational Site
Austin, Texas, United States, 78705
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01529346     History of Changes
Other Study ID Numbers: B3291009
Study First Received: December 13, 2011
Last Updated: August 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Postoperative dental pain

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

ClinicalTrials.gov processed this record on August 18, 2014