(-) Efficacy of PF-04531083 in treating post-surgical dental pain (clinicaltrials.gov) - Jul 10, 2012 - P2, N=90; NCT01512160; Active, not recruiting -> Terminated (the reason for the trial termination was not specified).
Trial termination • Pain
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This study has been terminated.
( See termination reason in detailed description. )
First Received on August 30, 2011. Last Updated on July 10, 2012 History of ChangesSponsor:PfizerInformation provided by (Responsible Party):PfizerClinicalTrials.gov Identifier:NCT01512160 PurposeThe purpose of this study is to evaluate the overall pain relief of a single dose of PF-04531083 against placebo following third molar extraction.
Condition
Post-surgical Dental Pain
Intervention
Drug: PF-04531083
Other: Placebo
Drug: Ibuprofen
Phase
Phase 2
Study Type:InterventionalStudy Design:Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: TreatmentOfficial Title:A Randomized, Double-Blind Third Party Open, Double-Dummy, Parallel Group, Placebo Controlled Study Assessing The Efficacy Of Single Doses Of Pf-04531083 For The Treatment Of Post-Surgical Dental Pain Using Ibuprofen 400 Mg As A Positive Control
Resource links provided by NLM:
Drug Information available for: Ibuprofen Ibuprofen lysinateU.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:Total pain relief through 6 hours (TOTPAR[6]), defined as the area under the Pain Relief (PR) curve through the first 6 hours after dosing. [ Time Frame: 0-6 h post-dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:Peak Pain Relief (PPR) [ Time Frame: 0-24 h post-dose ] [ Designated as safety issue: No ]
Time-specific Pain Relief (PR) [ Time Frame: 0-24 h post-dose ] [ Designated as safety issue: No ]
Time-specific Pain Intensity Difference (PID) [ Time Frame: 0-24 h post-dose ] [ Designated as safety issue: No ]
Summed pain intensity difference (SPID) [ Time Frame: 6h and 24h post-dose ] [ Designated as safety issue: No ]
Total pain relief TOTPAR[24] (area under the PR curve through the first 24 hours post-dose) [ Time Frame: 0-24 h post-dose ] [ Designated as safety issue: No ]
Time to perceptible 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 of they feel any pain relieving effect. [ Time Frame: 0-6 h post-dose ] [ Designated as safety issue: No ]
Time to meaningful 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 that pain relief is meaningful to them. [ Time Frame: 0-6 h post-dose ] [ Designated as safety issue: No ]
Time of, type, dose and reason for rescue medication [ Time Frame: 0-6 h post-dose ] [ Designated as safety issue: No ]
Patient's Global Evaluation of Study Medication [ Time Frame: 6h and 24h post-dose and at time of rescue medication ] [ Designated as safety issue: No ]
Patient Satisfaction Questionnaire [ Time Frame: 6h and 24h post-dose and at time of rescue medication ] [ Designated as safety issue: No ]
PK profile of PF-04531083 and ibuprofen [ Time Frame: Up to 24 h post-dose ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: Up to 28 days post-dose ] [ Designated as safety issue: Yes ]
Lab safety [ Time Frame: Screen; Baseline; 24 h post-dose; Day 10-14 (Follow-up) ] [ Designated as safety issue: Yes ]
Blood Pressure [ Time Frame: Screen; Baseline; Immediately prior to dosing on day 1; 24 h post-dose; Day 10-14 (Follow-up) ] [ Designated as safety issue: Yes ]
Pulse rate [ Time Frame: Screen; Baseline; Immediately prior to dosing on day 1; 24 h post-dose; Day 10-14 (Follow-up) ] [ Designated as safety issue: Yes ]
Electrocardiogram (ECG) [ Time Frame: Screen; 6 h, 24 h post-dose; Day 10-14 (Follow-up) ] [ Designated as safety issue: Yes ]
Enrollment:90
Study Start Date:October 2011
Study Completion Date:April 2012
Primary Completion Date:March 2012 (Final data collection date for primary outcome measure)
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