Ketoprofen Lysine Salt as Mouthwash in Acute Phlogosis of... | NCT02178293

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

NCT02178293

Sponsor

Boehringer Ingelheim

Status

Completed

Last Update Posted

Jul 8, 2014Estimated

Enrollment

214Actual

Phase

Phase 4

Conditions

Pharyngitis

Interventions

Benzidamine hydrochloride
Ketoprofen lysine salt

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1998

Primary Completion Date

May 1999Actual

Completion Date

Not provided

First Submitted Date

Jun 27, 2014

First Submission Date that Met QC Criteria

Jun 27, 2014

First Posted Date

Jun 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2014

Last Update Posted Date

Jul 8, 2014Estimated

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

214Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Benzidamine hydrochloride	Active Comparator		Drug: Benzidamine hydrochloride
Ketoprofen lysine salt	Experimental		Drug: Ketoprofen lysine salt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Benzidamine hydrochloride	Drug		Benzidamine hydrochloride
Ketoprofen lysine salt

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of analgesic effects in hours		Up to 6 hours

Secondary Outcomes

Measure	Description	Time Frame
Average number of days required to obtain remission of pain	day on which 2 consecutive pain measurements are both below 10 mm of the visual analog scale (VAS)	Up to day 8
Average severity of edema and hyperemia, assessed by investigator on a 4-point-scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010612	Pharyngitis

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010608	Pharyngeal Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided