A Randomised Double Blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of 2 Doses of Ketoprofen Lysinate Lozenges (6.25 mg & 12.5 mg) in Patients With Sore Throat
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 801
- Locations
- 1
- Primary Endpoint
- The TOTPAR15-120 which is the sum of each pain relief scale score
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Ketoprofen lysinate 12.5 mg
Intervention: KETOPROFEN(RP19583) (Drug)
Ketoprofen lysinate 6.25 mg
Intervention: KETOPROFEN(RP19583) (Drug)
Matching placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
The TOTPAR15-120 which is the sum of each pain relief scale score
Time Frame: measured every 15 minutes during the 2 hours following the first study drug intake
Secondary Outcomes
- 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)