KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges

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

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 Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: KETOPROFEN(RP19583); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 801
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Sanofi-Aventis Administrative Office
• Finland
  • Helsinki, Finland
    • Sanofi-Aventis Administrative Office
• France
  • Paris, France
    • Sanofi-Aventis Administrative Office
• Germany
  • Frankfurt, Germany
    • Sanofi-Aventis Administrative Office
• Mexico
  • Col. Coyoacan, Mexico
    • Sanofi-Aventis Administrative Office
• Russian Federation
  • Moscow, Russian Federation
    • Sanofi-Aventis Administrative Office
• Spain
  • Barcelona, Spain
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Patients with a sore throat associated or not with an URTI > or = 24 hours and < or = 6 days' duration, in the absence of A.Streptococcus*,
• Evidence of tonsillo-pharyngitis (TPA score > or = 5) at inclusion,
• With a score of throat soreness > or = 6 (0-10 ordinal scale),
• With a perception of swollen throat > or = 60mm (VAS),
• With a global throat pain intensity such as pain at swallowing

• assessed by a VAS > or = 60 mm.

  *Specific exploration at Inclusion:

• The Score of Mac Isaac will be performed by the investigator.
• Presence of streptococcus will be assessed by a throat swab test Patients having a positive swab test will not be included.

Exclusion criteria:

• Patients having used any local medication containing a local oral anesthetic such as lozenge, spray, mouth rinse or any topical throat treatment within 2 hours before study entry
• Patients with positive throat swab test for A.Streptococcus pharyngitis
• Patients having used analgesics within 4 hours before study entry
• Patients having used any long-acting or slow release analgesics within 12 hours before study entry
• Patients having used any anti inflammatory treatment 8-12 hours before study entry
• Patients having used any anti histaminic 8-12 hours before study entry
• Patients with pharyngeal paresthesia
• Patients with pharyngeal mycosis
• Patients with known history of ketoprofen, aspirin or other NSAID-induced bronchospasm
• Hypersensitivity to ketoprofen or its excipients
• Any disease that could compromise breathing such as bronchopneumonia or asthma
• Evidence of mouth-breathing or uncomfortable coughing
• Any chronic disease that requires a long period anti-inflammatory treatment
• Any chronic disease that requires long term use of anticoagulants or use of anticoagulants or anti-platelet agents one week before study entry,
• Women known to be pregnant.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ketoprofen lysinate 12.5 mg	Drug: KETOPROFEN(RP19583); Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days
EXPERIMENTAL: Ketoprofen lysinate 6.25 mg	Drug: KETOPROFEN(RP19583); Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days
PLACEBO_COMPARATOR: Matching placebo	Drug: Placebo; Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (ACTUAL): April 1, 2010
• Study Completion (ACTUAL): April 1, 2010

Study Registration Dates

• First Submitted: June 29, 2009
• First Submitted That Met QC Criteria: June 29, 2009
• First Posted (ESTIMATE): June 30, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 18, 2010
• Last Update Submitted That Met QC Criteria: May 17, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketoprofen
• Other Study ID Numbers: KETOP_C_03968; 2008-008265-36(EudraCT)