Back to results

KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges

Primary Purpose

Pain

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

KETOPROFEN(RP19583)

Placebo

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketoprofen lysinate 12.5 mg

Ketoprofen lysinate 6.25 mg

Matching placebo

Arm Description

Outcomes

Primary Outcome Measures

The TOTPAR15-120 which is the sum of each pain relief scale score

Secondary Outcome Measures

The TOTPAR15-360 which is the sum of each pain relief scale score

The global throat pain intensity

The morning pain relief scale score

The evening pain relief scale score

Full Information

NCT ID

NCT00929877

First Posted

June 29, 2009

Last Updated

May 17, 2010

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00929877

Brief Title

KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

801 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketoprofen lysinate 12.5 mg

Arm Type

Experimental

Arm Title

Ketoprofen lysinate 6.25 mg

Arm Type

Experimental

Arm Title

Matching placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

KETOPROFEN(RP19583)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

KETOPROFEN(RP19583)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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.

Title

The global throat pain intensity

Time Frame

assessed every 15 min during 2 hours after the first study drug intake

Title

The morning pain relief scale score

Time Frame

measured in morning of days 1, 2 and 3

Title

The evening pain relief scale score

Time Frame

measured in evening of days 1, 2 and 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gilles Perdriset

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name