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Acute Sore Throat Pain Study

Primary Purpose

Acute Sore Throat Pain

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo

Ibuprofen 35 mg

Ibuprofen 25 mg

Ibuprofen 15 mg

Strefen

About this trial

This is an interventional treatment trial for Acute Sore Throat Pain focused on measuring sore throat pain, tonsillopharyngitis, upper respiratory tract infection

Eligibility Criteria

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

Inclusion Criteria:

male or female patients 18 years and older
patients with a sore throat associated or not with an Upper Respiratory Tract Infection ≥ 24 hours and ≤ 5 days duration, in the absence of Streptococcus group A

Exclusion Criteria:

patients with hypersensitivity to Ibuprofen or other NSAIDs or the excipients.
patients having used analgesics or antiseptics or any topical throat treatment or any local medication containing a local oral anaesthetic within 6 hours before study entry and who use analgesics more than ≥ 3 times per week.
patients having used any anti inflammatory treatment or any long-acting or slow release analgesics within 12 hours before study entry
patients having taken antibiotics within 14 days before study entry.

Sites / Locations

Eurofins Optimed
Eurofins Optimed Lyon

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Other

Arm Label

Placebo

V0498TA01A 15 mg

V0498TA01A 25 mg

V0498TA01A 35 mg

Strefen

Arm Description

Positive control

Outcomes

Primary Outcome Measures

Change from baseline of Sore Throat Pain Intensity Scale

Secondary Outcome Measures

Change from baseline of Sore Throat Pain relief Scale

Change of Sore Throat Pain Intensity Scales

Local tolerability examination

Mouth examination including extent of erythema, edema, petechial hemorrhages, ulceration (4 point scale : none, mild, moderate and severe).

General tolerability (reported adverse events)

Full Information

NCT ID

NCT01535079

First Posted

February 10, 2012

Last Updated

November 9, 2012

Sponsor

Pierre Fabre Medicament

1. Study Identification

Unique Protocol Identification Number

NCT01535079

Brief Title

Acute Sore Throat Pain Study

Official Title

Analgesic Profile of 3 New Ibuprofen Lozenges (V0498TA01A 15 mg, 25 mg, 35 mg) After Single Administration in Acute Sore Throat Pain

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

February 2012 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pierre Fabre Medicament

4. Oversight

5. Study Description

Brief Summary

"Sore throat is one of the most common complaints encountered in clinical practice. And in 65% of cases, the infection is thought to be viral in nature. The aim of this study is to evaluate the analgesic profile of 3 Ibuprofen lozenges after single administration in acute sore throat pain."

6. Conditions and Keywords

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

Acute Sore Throat Pain

Keywords

sore throat pain, tonsillopharyngitis, upper respiratory tract infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

186 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

V0498TA01A 15 mg

Arm Type

Experimental

Arm Title

V0498TA01A 25 mg

Arm Type

Experimental

Arm Title

V0498TA01A 35 mg

Arm Type

Experimental

Arm Title

Strefen

Arm Type

Other

Arm Description

Positive control

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single administration

Intervention Type

Drug

Intervention Name(s)

Ibuprofen 35 mg

Intervention Description

Single administration

Intervention Type

Drug

Intervention Name(s)

Ibuprofen 25 mg

Intervention Description

Single administration

Intervention Type

Drug

Intervention Name(s)

Ibuprofen 15 mg

Intervention Description

Single administration

Intervention Type

Drug

Intervention Name(s)

Strefen

Intervention Description

Single administration

Primary Outcome Measure Information:

Title

Change from baseline of Sore Throat Pain Intensity Scale

Time Frame

60 minutes

Secondary Outcome Measure Information:

Title

Change from baseline of Sore Throat Pain relief Scale

Time Frame

up to 360 minutes

Title

Change of Sore Throat Pain Intensity Scales

Time Frame

up to 360 minutes

Title

Local tolerability examination

Description

Mouth examination including extent of erythema, edema, petechial hemorrhages, ulceration (4 point scale : none, mild, moderate and severe).

Time Frame

Baseline (before drug intake) and 360 minutes

Title

General tolerability (reported adverse events)

Time Frame

Baseline (before drug intake) and 360 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: male or female patients 18 years and older patients with a sore throat associated or not with an Upper Respiratory Tract Infection ≥ 24 hours and ≤ 5 days duration, in the absence of Streptococcus group A Exclusion Criteria: patients with hypersensitivity to Ibuprofen or other NSAIDs or the excipients. patients having used analgesics or antiseptics or any topical throat treatment or any local medication containing a local oral anaesthetic within 6 hours before study entry and who use analgesics more than ≥ 3 times per week. patients having used any anti inflammatory treatment or any long-acting or slow release analgesics within 12 hours before study entry patients having taken antibiotics within 14 days before study entry.

Facility Information:

Facility Name

Eurofins Optimed

City

Gières

Country

France

Facility Name

Eurofins Optimed Lyon

City

Pierre Bénite

Country

France

City

Erfurt

Country

Germany

City

Cardiff

Country

United Kingdom

12. IPD Sharing Statement

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Acute Sore Throat Pain Study

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