EUCTR2021-002058-96-BG
Active, not recruiting
Phase 1
Efficacy and safety of the combination of acetylcysteine, paracetamol and phenylephrine for the treatment of common cold: a prospective, randomized, double-blind, controlled trial - non available
ek Pharmaceuticals d.d.0 sites1,002 target enrollmentAugust 16, 2021
ConditionsCommon cold and flu-like infectionsMedDRA version: 22.1Level: LLTClassification code 10010106Term: Common coldSystem Organ Class: 100000004862MedDRA version: 20.1Level: LLTClassification code 10000938Term: Acute nasopharyngitis (common cold)System Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Common cold and flu-like infections
- Sponsor
- ek Pharmaceuticals d.d.
- Enrollment
- 1002
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\[1] Male or female subjects aged between 18 and 75 years inclusive on the date of consent
- •\[2] No fever or (mild) fever below 38\.5° C
- •\[3] Total score (sum of all ratings) of 2 or higher based on the rating of the following symptoms of common cold (Jackson scale):
- •a. Sneezing
- •b. Nasal discharge
- •c. Nasal obstruction
- •d. Sore throat
- •f. Headache
- •h. Chilliness
- •according to the following rating scale: 0 \= absent, 1 \= mild, 2 \= moderate, or 3 \= severe
Exclusion Criteria
- •Exclusion criteria
- •\[1] Duration of any of the symptoms of common cold of more than 72 hours at the time of screening
- •\[2] History of hypersensitivity or intolerance to the active substances or any of the excipients of the trial medication
- •\[3] Known bronchial asthma or chronic obstructive pulmonary disease
- •\[4] Known duodenal or gastric ulcer
- •\[5] Known hyperthyroidism
- •\[6] Known narrow angle glaucoma
- •\[7] Known pheochromocytoma
- •\[8] Known prostate adenoma with urine retention
- •\[9] Known severe liver failure (Child\-Pugh \> 9\)
Outcomes
Primary Outcomes
Not specified
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