An interventional study of Angiflash and Placebo in Sore Throat, sponsored by Laboratoire de la Mer. Status unknown at 16 sites in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-22.
Sponsored by Laboratoire de la Mer · Not applicable, Interventional, and Treatment
Prospective, randomized, double-blind, placebo-controlled, multicentre clinical trial to assess the efficacy and tolerability of natural seawater based throat spray among adult patients with acute sore throat.
226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.
This study's planned enrollment of 360 is above the median of 144 across 188 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →Laboratoire de la Mer is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Compared within Pharyngitis, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
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.
Exclusion Criteria:
Subjects taking:
Subjects refusing to stop at entry into the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Angiflash
Device: Placebo
throat spray (20 ml) containing hypertonic seawater, vegetable glycerin, natural mint, acacia honey, propolis extract, essential oils of thyme linalool, ravintsara and wintergreen, natural lemon flavor.
Also known as: Seawater based throat spray
water based throat spray matching Angiflash for posology, dispensed volume, shape and size.
Also known as: Placebo throat spray
Sore Throat Relief
Evaluation of sore throat relief using the 7-point sore throat relief scale (STRS)
Time frame: Over the first three days
Sore Throat Individual Symptoms Relief
Evaluation of relief of sore throat individual symptoms (dry throat, burning/painful sensation, hoarseness/husky voice, painful talk, painful swallowing, irritation, prickly sensation/tingle, scratchy/itchy throat) using a 10-point rating scale
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Sore Throat Pain Intensity
Change from baseline of the Sore Throat Pain Intensity using a Visual Analog Scale (VAS) (STPIS)
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Difficulty Swallowing
Change from baseline of the difficulty of swallowing using a VAS (DSS)
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Swollen Throat
Change from baseline of the swollen throat using a VAS (SwoTS)
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Overall efficacy assessed by the physician
Overall efficacy assessed by the physician using a 5-point descriptive scale
Time frame: Day 8
Compliance: assessment of the number of use per day and the number of spray per use
Assessment of the patient usage: frequency per day and number of spray per use
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Product Satisfaction
Assessment of the overall satisfaction using a 5-point descriptive scale
Time frame: Day 8
Incidence of adverse events occuring during the study
Number of adverse events and serious events occuring during the study and evaluation of the severity and causality.
Time frame: Day 1, 2, 3, 4, 5, 5, 7 to 8.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Laboratoire de la Mer