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

NCT ID: NCT05070650

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2025-04-30

Brief Summary

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

Detailed Description

This study is a prospective, randomized, multinational, multicenter, double-blind trial in 2 parallel groups of patients.

Patients will undergo screening examinations at Visit 1.

Patients who meet all of the inclusion and none of the exclusion criteria will be randomized to double-blind treatment with one of the following:

• Group A: Acetylcysteine/Paracetamol/Phenylephrine: one sachet three times per day OR
• Group B: Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution: one sachet three times per day.

A control visit (Visit 2) is planned on Day 3 of treatment.

After the end of the double-blind treatment phase, the patients will undergo an end-of-treatment (EOT) examination at Visit 3 on Day 6.

Conditions

Common Cold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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

Group Type: EXPERIMENTAL

Acetylcysteine

Intervention Type: DRUG

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

Paracetamol

Intervention Type: DRUG

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

Phenylephrine

Intervention Type: DRUG

500 mg/10 mg granules for oral solution

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

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

Group Type: ACTIVE_COMPARATOR

Paracetamol

Intervention Type: DRUG

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

Phenylephrine

Intervention Type: DRUG

500 mg/10 mg granules for oral solution

Interventions

Acetylcysteine

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

Intervention Type: DRUG

Paracetamol

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

Intervention Type: DRUG

Phenylephrine

500 mg/10 mg granules for oral solution

Intervention Type: DRUG

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):

1. Sneezing

2. Nasal discharge

3. Nasal obstruction

4. Sore throat

5. Cough

6. Headache

7. Malaise

8. Chilliness according to the following rating scale: 0 = absent, 1 = mild, 2 = moderate, or 3 = severe

4. Presence of cough with thick mucus production

5. Informed consent to participate in the trial provided in written form

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)

10. Known severe cardio-vascular diseases

11. Known porphyria

12. Known glucose-6-phosphate dehydrogenase deficiency

13. High fever (body temperature above 38.5°C)

14. Intake of antibiotics, immunosuppressing, immuno-stimulating or immuno-modulating medication, within 30 days prior to screening visit

15. Intranasal or systemic use of corticosteroids within 30 days prior to screening visit

16. Intake of antihistamines or nasal decongestants within 48 hours prior to screening visit

17. Vaccination within 14 days prior to screening visit

18. Immunocompromised state

19. Suspicion for acute bacterial infection

20. Pregnant or breast-feeding female patient

21. Female patient of childbearing potential (not surgically sterilized/ hysterectomized or postmenopausal for at least 1 year) who is not currently using (documented at screening visit) and not willing to use medically reliable methods of contraception for the entire trial duration such as barrier method, oral, injectable or implantable contraceptives, intrauterine contraceptive devices (IUD), sexual abstinence or vasectomized partner

22. Any other condition of the patient (e.g. serious or unstable medical or psychological condition, acute psychosis) that in the opinion of the investigator may compromise evaluation of the trial treatment or may jeopardize patient's safety, compliance or adherence to protocol requirements

23. Participation in ANY research study involving another investigational medicinal product (IMP) within 30 days prior to screening visit, or simultaneous participation in another clinical study or previous participation in present study

24. Suspected alcohol/ drug dependence or abuse (including heavy smoking: ≥ 20 cigarettes daily)

25. Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial

26. Subjects who are known or suspected:

• not to comply with the trial directives
• not to be reliable or trustworthy
• to be a dependent person, e.g. a relative, family member, or member/ employee of the investigator's or sponsor's staff
• subject is in custody or submitted to an institution due to a judicial order.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sandoz

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

SAN-0657

Identifier Type: -

Identifier Source: org_study_id