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KRYSTAL- KetopRofen lYsinate Sore ThroAt Lozenges

NCT00929877 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 801

Last updated 2010-05-18

No results posted yet for this study

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

Interventions

DRUG

KETOPROFEN(RP19583)

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

DRUG

KETOPROFEN(RP19583)

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Gilles Perdriset · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Egypt
  • Finland
  • France
  • Germany
  • Mexico
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00929877 on ClinicalTrials.gov