Pharyngitis Clinical Trial
— MISTRALOfficial title:
MISTRAL (Mouthwash In Sore Throat Relief: Antiinflammatory vs. Local Anesthetic Therapy) "Efficacy and Tolerability of Ketoprofen Lysine Salt as a Mouthwash in Acute Phlogosis of the Pharyngeal Cavity; Multicentre, Randomized, Single-blind, Parallel-group Comparison Versus Benzidamine Hydrochloride"
NCT number | NCT02178293 |
Other study ID # | 1087.7 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | June 27, 2014 |
Last updated | July 4, 2014 |
Start date | September 1998 |
Verified date | July 2014 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
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
Status | Completed |
Enrollment | 214 |
Est. completion date | |
Est. primary completion date | May 1999 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of analgesic effects in hours | Up to 6 hours | No | |
Secondary | 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 | No |
Secondary | Average severity of edema and hyperemia, assessed by investigator on a 4-point-scale | Up to day 8 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01453400 -
Evaluate the Time of Pain Relief of Fast Acting Aspirin Versus Acetaminophen in Subjects Diagnosed With Sore Throat Pain
|
Phase 3 | |
Completed |
NCT04016051 -
Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections
|
Phase 3 | |
Recruiting |
NCT01681667 -
Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain
|
Phase 4 | |
Completed |
NCT00527852 -
Assessment of Flocked Swabs for the Identification of Group A Streptococcal Pharyngitis
|
N/A | |
Active, not recruiting |
NCT05127161 -
Broad Implementation of Outpatient Stewardship
|
N/A | |
Withdrawn |
NCT02535962 -
Probiotics and Corticosteroids for Treating Periodic Fever, Aphthous Stomatitis, Pharyngitis, Cervical Adenitis (PFAPA)
|
Phase 2 | |
Not yet recruiting |
NCT02252419 -
Combined Effect of Dexamethasone and Paracetamol for Postoperative Sore Throat
|
N/A | |
Completed |
NCT00798018 -
Effect of Intra-cuff Lidocaine and Tetracaine on Tracheal Tube-induced Emergence Phenomena
|
N/A | |
Completed |
NCT00535093 -
An Assessment of Rapid Streptococcal Tests in Community Clinics in Israel
|
N/A | |
Completed |
NCT00148499 -
Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis
|
Phase 3 | |
Completed |
NCT00095368 -
APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat
|
Phase 3 | |
Recruiting |
NCT06027593 -
Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions
|
N/A | |
Recruiting |
NCT03720301 -
The Use of Osteopathic Medical Manipulation to Decrease the Incidence and Severity of Post-Operative Sore Throat
|
N/A | |
Completed |
NCT01361399 -
Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold
|
Phase 3 | |
Completed |
NCT01048866 -
A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis
|
Phase 3 | |
Completed |
NCT01398696 -
Impact of Four Patient Information Leaflets (PIL) on Patient Behaviour
|
Phase 4 | |
Completed |
NCT01049334 -
A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis
|
Phase 3 | |
Completed |
NCT00547391 -
Recurrent Throat Infections and Tonsillectomy
|
Phase 4 | |
Completed |
NCT00242281 -
APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat
|
Phase 3 | |
Completed |
NCT01465009 -
Placebo and Active Controlled Study to Compare the Efficacy of Aspirin and Paracetamol in Treatment of Sore Throat Associated With a Common Cold
|
Phase 4 |