KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00929877
First received: June 29, 2009
Last updated: May 17, 2010
Last verified: May 2010
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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:
MedlinePlus related topics:
Sore Throat
Drug Information available for:
Ketoprofen
U.S. FDA Resources
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
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 May 19, 2013