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

Sandoz

Status and phase: Withdrawn; Phase 3

Conditions: Common Cold

Treatments: Drug: Acetylcysteine; Drug: Phenylephrine; Drug: Paracetamol

Study type: Interventional

Funder types: Industry

Identifiers

NCT05070650

SAN-0657

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Drug: Paracetamol

Drug: Phenylephrine

Drug: Acetylcysteine

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

Active Comparator group

Description:

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

Treatment:

Drug: Paracetamol

Drug: Phenylephrine