Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold

NCT05070650 | Withdrawn Phase 3

• 1 other identifier: SAN-0657
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective, randomized, multinational, multicenter, double-blind trial in 2 parallel groups of patients

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the daily Score of 8 symptoms related to mucus production (SUM8)

  Score of 8 symptoms related to mucus production (SUM8) will be assessed by the patient in a patient's diary at screening (this will constitute the baseline value) and daily on each day of treatment until and including Day 5. For assessing SUM8 the patients will have to answer questions about their cough and phlegm status. The SUM8 consisted of the sum of the answers to the eight core questions. For calculating the SUM8 the lowest rating corresponds to 0 and highest rating corresponds to 4, with 4 representing the greatest severity of symptoms. The SUM8 thus had a scale range of 0-32 with 0 representing best possible symptoms, and 32 representing greatest severity of symptoms.

  Baseline, Day 5

Secondary Outcomes (7)

• Number of adverse events and serious adverse events

  Until Day 6, or earlier in case of premature termination

• Time to onset of action

  Day 1 to Day 5

• Score of 8 symptoms related to mucus production (SUM8) development over the course of the study

  Baseline, Day 1 to Day 5

• Assessment of separate items of Score of 8 symptoms related to mucus production (SUM8)

  Baseline, Day 1 to Day 5

• Sum of changes from baseline in the daily Wisconsin Upper Respiratory Symptom Survey (WURSS-21)

  Baseline, Day 1 to Day 5

Study Arms (2)

Acetylcysteine/Paracetamol/Phenylephrine 200 mg/500 mg/10 mg granules for oral solution

EXPERIMENTAL

Acetylcysteine/Paracetamol/Phenylephrine 200 mg/500 mg/10 mg granules for oral solution: one sachet three times per day

Drug: Acetylcysteine; Drug: Paracetamol; Drug: Phenylephrine

Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution

ACTIVE COMPARATOR

Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution: one sachet three times per day

Drug: Paracetamol; Drug: Phenylephrine

Interventions

Acetylcysteine DRUG

200 mg/500 mg/10 mg granules for oral solution: one sachet three times per day

Acetylcysteine/Paracetamol/Phenylephrine 200 mg/500 mg/10 mg granules for oral solution

Paracetamol DRUG

500 mg/10 mg granules for oral solution: one sachet three times per day

Acetylcysteine/Paracetamol/Phenylephrine 200 mg/500 mg/10 mg granules for oral solution; Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution

Phenylephrine DRUG

500 mg/10 mg granules for oral solution

Acetylcysteine/Paracetamol/Phenylephrine 200 mg/500 mg/10 mg granules for oral solution; Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged between 18 and 75 years inclusive on the date of consent
• No fever or (mild) fever below 38.5° C
• Total score (sum of all ratings) of 2 or higher based on the rating of the following symptoms of common cold (Jackson scale):
• Sneezing
• Nasal discharge
• Nasal obstruction
• Sore throat
• Cough
• Headache
• Malaise
• Chilliness according to the following rating scale: 0 = absent, 1 = mild, 2 = moderate, or 3 = severe
• Presence of cough with thick mucus production
• Informed consent to participate in the trial provided in written form

You may not qualify if:

• Duration of any of the symptoms of common cold of more than 72 hours at the time of screening
• History of hypersensitivity or intolerance to the active substances or any of the excipients of the trial medication
• Known bronchial asthma or chronic obstructive pulmonary disease
• Known duodenal or gastric ulcer
• Known hyperthyroidism
• Known narrow angle glaucoma
• Known pheochromocytoma
• Known prostate adenoma with urine retention
• Known severe liver failure (Child-Pugh \> 9)
• Known severe cardio-vascular diseases
• Known porphyria
• Known glucose-6-phosphate dehydrogenase deficiency
• High fever (body temperature above 38.5°C)
• Intake of antibiotics, immunosuppressing, immuno-stimulating or immuno-modulating medication, within 30 days prior to screening visit
• Intranasal or systemic use of corticosteroids within 30 days prior to screening visit

Sponsors & Collaborators

• Sandoz: lead

MeSH Terms

Conditions

Common Cold

Interventions

Acetylcysteine; Acetaminophen; Phenylephrine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 7, 2021
• Study Start: September 20, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share