An Analgesic Study to of V117957 for the Treatment of Postsurgical Pain Due to Third Molar Extraction

Phase 2

Terminated

• Conditions: Postsurgical Pain Due to Third Molar Extraction
• Interventions: Drug: V117957; Drug: Ibuprofen; Drug: Placebo

• Registration Number: NCT01900795
• Lead Sponsor: Purdue Pharma LP

Brief Summary

The primary objective of this study is to assess the analgesic properties of an oral dose of V117957 4.5 mg aqueous suspension in the third molar extraction model

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-16
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-03
• Last Update Posted: 2013-12-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V117957	V117957	-
Ibuprofen	Ibuprofen	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Total pain relief 0 to 8 hours after dosing (TOTPAR8)	0 - 8 hours postdose	Time-weighted sum of pain relief scores 0 to 8 hours after dosing

Secondary Outcome Measures

Name	Time	Method
Sum of pain intensity difference 0 to 6 hours after dosing (SPID6)	Hour 6 postdose
Sum of pain intensity difference 0 to 8 hours after dosing (SPID8)	Hour 8 postdose
Total Pain Relief 0 - 4 hours after dosing (TOTPAR4)	Hour 4 postdose
Total Pain Relief 0 - 6 hours after dosing (TOTPAR6)	Hour 6 postdose
Total Pain Relief 0 - 12 hours after dosing (TOTPAR12)	Hour 12 postdose
Total Pain Relief 0 - 24 hours after dosing (TOTPAR24)	Hour 24 postdose
Pain Relief (PR) over time	Up to 24 hours postdose
Pain intensity difference over time	15, 30, 45 , 60, 90 minutes; 2, 3, 4, 4.5, 6, 8, 10, 12 and 24 hours postdose
Sum of pain intensity difference 0 to 4 hours after dosing (SPID4)	Hour 4 postdose
Sum of pain intensity difference 0 to 12 hours after dosing (SPID12)	Hour 12 postdose
Sum of pain intensity difference 0 to 24 hours after dosing (SPID24)	Hour 24 postdose
Time to first perceptible PR	Up to 24 hours postdose
Time to meaningful PR	Up to 24 hours postdose
Time to first use of rescue pain medication	Up to 24 hours postdose
Proportion of subjects taking rescue medication by time point	Up to 24 hours postdose
Global assessment of overall satisfaction	Hour 24 postdose

Trial Locations

Locations (1)

PPD Dental Pain Clinic; 🇺🇸 Austin, Texas, United States