KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: KETOPROFEN(RP19583); Drug: Placebo

• Registration Number: NCT00929877
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25 mg and 12.5 mg ketoprofen base) with placebo, on total pain relief summed over 15 to 120 min (TOTPAR15-120) after the first intake of study drug.

Secondary Objectives:

To compare the single-dose efficacy of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) with placebo after the first intake on:

* the total pain relief summed over 15 to 360min (TOTPAR15-360)

* the changes from baseline of global throat pain intensity assessed over 15 to 120min and over 15 to 360min.

* the changes from baseline of throat soreness over 15 to 120min and over 15 to 360min

* the changes from baseline of swollen throat over 15 to 120min and over 15 to 360min To compare pain relief, global throat pain intensity, throat soreness and swollen throat in the evening of days 1, 2 and 3

To evaluate the safety of ketoprofen lysinate lozenges (6.25mg and 12.5mg ) and placebo at follow-up visit on:

Day 4: - adverse events and clinical examination Day 7: - adverse events reporting (followed by a clinical examination if needed)

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-29
• Study First Submitted QC: 2009-06-29
• Study First Posted: 2009-06-30
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-17
• Last Update Posted: 2010-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 801

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketoprofen lysinate 6.25 mg	KETOPROFEN(RP19583)	-
Ketoprofen lysinate 12.5 mg	KETOPROFEN(RP19583)	-
Matching placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
The TOTPAR15-120 which is the sum of each pain relief scale score	measured every 15 minutes during the 2 hours following the first study drug intake

Secondary Outcome Measures

Name	Time	Method
The morning pain relief scale score	measured in morning of days 1, 2 and 3
The evening pain relief scale score	measured in evening of days 1, 2 and 3
The TOTPAR15-360 which is the sum of each pain relief scale score	Measured every 15 minutes during the 2 hours following the first study drug intake at study site then every hour up to 6 hours as outpatient.
The global throat pain intensity	assessed every 15 min during 2 hours after the first study drug intake

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇪🇸 Barcelona, Spain