Ketoprofen Lysine Salt as Mouthwash in Acute Phlogosis of the Pharyngeal Cavity Versus Benzidamine Hydrochloride

NCT ID: NCT02178293

Last Updated: 2014-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-09-30

Brief Summary

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A study to in order to verify any differences between the 2 treatment groups in terms of duration of analgesic effects after the first drug intake and time to remission of symptoms and signs of pharyngitis

Detailed Description

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Conditions

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Pharyngitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Study Groups

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Benzidamine hydrochloride

Group Type ACTIVE_COMPARATOR

Benzidamine hydrochloride

Intervention Type DRUG

Ketoprofen lysine salt

Group Type EXPERIMENTAL

Ketoprofen lysine salt

Intervention Type DRUG

Interventions

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Benzidamine hydrochloride

Intervention Type DRUG

Ketoprofen lysine salt

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female outpatients, aged 18 to 70 years, suffering from acute pharyngitis, pharyngolaryngitis
* Moderately or severely intense pain in the pharyngeal region (score ≥ 70 mm) from the "visual analogue scale" (VAS)
* At least 1 of the 2 inflammation signs (edema and hyperemia) to be moderately or severely intense (score ≥ 2) from the scoring scale from 0 to 3
* Release of written informed consent by the patient

Exclusion Criteria

* Patients suffering from a microbial infection requiring specific antimicrobial treatment
* Patients who have taken the trial drugs during the week before enrolment
* Patients who have taken corticosteroids or antibiotics during the week before enrolment
* Ascertained or suspected hypersensitivity to trial drugs or to chemically correlated drugs or to other non-steroidal anti-inflammatory drugs or to mouthwashes in general
* Patients who are unable to properly fill in the diary every day as provided for by the protocol
* Ascertained or presumed pregnant or lactating women
* Inclusion in any other clinical trial during the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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1087.7

Identifier Type: -

Identifier Source: org_study_id

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