KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00929877
First received: June 29, 2009
Last updated: May 17, 2010
Last verified: May 2010
  Purpose

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)


Condition Intervention Phase
Pain
Drug: KETOPROFEN(RP19583)
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The TOTPAR15-360 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 at study site then every hour up to 6 hours as outpatient. ] [ Designated as safety issue: No ]
  • The global throat pain intensity [ Time Frame: assessed every 15 min during 2 hours after the first study drug intake ] [ Designated as safety issue: No ]
  • The morning pain relief scale score [ Time Frame: measured in morning of days 1, 2 and 3 ] [ Designated as safety issue: No ]
  • The evening pain relief scale score [ Time Frame: measured in evening of days 1, 2 and 3 ] [ Designated as safety issue: No ]

Enrollment: 801
Study Start Date: June 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929877

Locations
Egypt
Sanofi-Aventis Administrative Office
Cairo, Egypt
Finland
Sanofi-Aventis Administrative Office
Helsinki, Finland
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Frankfurt, Germany
Mexico
Sanofi-Aventis Administrative Office
Col. Coyoacan, Mexico
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Gilles Perdriset Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00929877     History of Changes
Other Study ID Numbers: KETOP_C_03968, 2008-008265-36(EudraCT)
Study First Received: June 29, 2009
Last Updated: May 17, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 20, 2014