KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929877
• Other study ID #: KETOP_C_03968
• Secondary ID: 2008-008265-36(E
• Status: Completed
• Phase: Phase 3
• First received: June 29, 2009
• Last updated: May 17, 2010
• Start date: June 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• KETOPROFEN(RP19583)
Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days
• KETOPROFEN(RP19583)
Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days
• Placebo
Oral administration up to a maximum of 5 lozenges within a 24-hour period during 3 days

Locations

Country	Name	City	State
Egypt	Sanofi-Aventis Administrative Office	Cairo
Finland	Sanofi-Aventis Administrative Office	Helsinki
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Frankfurt
Mexico	Sanofi-Aventis Administrative Office	Col. Coyoacan
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Spain	Sanofi-Aventis Administrative Office	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Egypt,  Finland,  France,  Germany,  Mexico,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	No
Secondary	The global throat pain intensity		assessed every 15 min during 2 hours after the first study drug intake	No
Secondary	The morning pain relief scale score		measured in morning of days 1, 2 and 3	No
Secondary	The evening pain relief scale score		measured in evening of days 1, 2 and 3	No