KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges

NCT ID: NCT00929877

Last Updated: 2010-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 801 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2010-04-30

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)

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ketoprofen lysinate 12.5 mg

Group Type: EXPERIMENTAL

KETOPROFEN(RP19583)

Intervention Type: DRUG

Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days

Ketoprofen lysinate 6.25 mg

Group Type: EXPERIMENTAL

KETOPROFEN(RP19583)

Intervention Type: DRUG

Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days

Matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days

Interventions

KETOPROFEN(RP19583)

Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days

Intervention Type: DRUG

KETOPROFEN(RP19583)

Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days

Intervention Type: DRUG

Placebo

Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Gilles Perdriset

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Cairo, , Egypt

Sanofi-Aventis Administrative Office

Helsinki, , Finland

Sanofi-Aventis Administrative Office

Paris, , France

Sanofi-Aventis Administrative Office

Frankfurt, , Germany

Sanofi-Aventis Administrative Office

Col. Coyoacan, , Mexico

Sanofi-Aventis Administrative Office

Moscow, , Russia

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Countries

Egypt; Finland; France; Germany; Mexico; Russia; Spain

Other Identifiers

2008-008265-36(EudraCT)

Identifier Type: -

Identifier Source: secondary_id

KETOP_C_03968

Identifier Type: -

Identifier Source: org_study_id