KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges

NCT00929877 | Completed Phase 3

• 2 other identifiers: KETOP_C_039682008-008265-36(EudraCT)
• Study Type: interventional
• Target: 801
• Locations: 7 countries
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (3)

Ketoprofen lysinate 12.5 mg

EXPERIMENTAL

Drug: KETOPROFEN(RP19583)

Ketoprofen lysinate 6.25 mg

EXPERIMENTAL

Drug: KETOPROFEN(RP19583)

Matching placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

KETOPROFEN(RP19583) DRUG

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

Ketoprofen lysinate 12.5 mg

Placebo DRUG

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

Matching placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\*,
• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (7)

Sanofi-Aventis Administrative Office

Cairo, Egypt

Location

Sanofi-Aventis Administrative Office

Helsinki, Finland

Location

Sanofi-Aventis Administrative Office

Paris, France

Location

Sanofi-Aventis Administrative Office

Frankfurt, Germany

Location

Sanofi-Aventis Administrative Office

Col. Coyoacan, Mexico

Location

Sanofi-Aventis Administrative Office

Moscow, Russia

Location

Sanofi-Aventis Administrative Office

Barcelona, Spain

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gilles Perdriset

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 18, 2010

Record last verified: 2010-05

Locations

ES (1); FI (1); FR (1); DE (1); EG (1); RU (1); ME (1)