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CompletedNCT02178293MISTRALUpdated Jul 8, 2014

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

A Phase 4 interventional study of Benzidamine hydrochloride and Ketoprofen lysine salt in Pharyngitis, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-07-08.

Sponsored by Boehringer Ingelheim · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
214
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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

02

Conditions studied

  • Pharyngitis

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03

In context

Pharyngitis

256 studies on the registry are indexed under Pharyngitis; 36 are open to participants now.

This study's enrollment of 214 is above the median of 143 across 211 interventional studies indexed under Pharyngitis.

Browse Pharyngitis studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.

Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
214 participants (actual)

Study arms

  • Active comparator
    Benzidamine hydrochloride

    Drug: Benzidamine hydrochloride

  • Experimental
    Ketoprofen lysine salt

    Drug: Ketoprofen lysine salt

06

What researchers measure

Primary outcomes

  1. Duration of analgesic effects in hours

    Time frame: Up to 6 hours

Secondary outcomes

  1. 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)

    Time frame: Up to day 8

  2. Average severity of edema and hyperemia, assessed by investigator on a 4-point-scale

    Time frame: Up to day 8

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 1998 and a primary completion of May 1999. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2014
First posted
Jun 30, 2014
Start
Sep 1998
Primary completionActual
May 1999
Last update
Jul 8, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02178293
Responsible party
Sponsor
First posted
Jun 30, 2014
Start date
Sep 1998
Primary completion
May 1999
Last update
Jul 8, 2014
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ketoprofen lysine

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