Common ColdPhase 3NCT05070650
Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold
A Phase 3 study testing Acetylcysteine, Paracetamol and Phenylephrine in people with Common Cold, run by Sandoz.
Trial summary
Prospective, randomized, multinational, multicenter, double-blind trial in 2 parallel groups of patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Common Cold
- What is being tested?
- Acetylcysteine, Paracetamol and Phenylephrine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2024to 30 Apr 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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
- Intake of antihistamines or nasal decongestants within 48 hours prior to screening visit
- Vaccination within 14 days prior to screening visit
- Immunocompromised state
- Suspicion for acute bacterial infection
- Pregnant or breast-feeding female patient
- 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
- 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
- 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
- Suspected alcohol/ drug dependence or abuse (including heavy smoking: ≥ 20 cigarettes daily)
- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial
- 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.
About this study
Official title: Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold: a Prospective, Randomized, Double-blind, Controlled Trial
Prospective, randomized, multinational, multicenter, double-blind trial in 2 parallel groups of patients
Read the 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
- Being tested
- Acetylcysteine, Paracetamol, Phenylephrine
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetylcysteineDrug
200 mg/500 mg/10 mg granules for oral solution: one sachet three times per day
ParacetamolDrug
500 mg/10 mg granules for oral solution: one sachet three times per day
PhenylephrineDrug
500 mg/10 mg granules for oral solution
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Paracetamol; Drug: Phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 5
Secondary outcomes (7)
Number of adverse events and serious adverse events
Assessment of safety and tolerability of the investigational medicinal product against the comparator product for the treatment of common cold
Measured: Until Day 6, or earlier in case of premature termination
Time to onset of action
Time to onset of action defined as first day of treatment with investigational product on which SUM8 shows statistically significant difference from the comparator product will be reported
Measured: Day 1 to Day 5
Score of 8 symptoms related to mucus production (SUM8) development over the course of the study
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.
Measured: Baseline, Day 1 to Day 5
Assessment of separate items of 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.
Measured: Baseline, Day 1 to Day 5
Sum of changes from baseline in the daily Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire is an evaluative illness-specific outcomes instrument designed to assess the severity of cold symptoms and the impact of the common cold (range 0-140), with higher scores indicating more symptoms and functional impairment.
Measured: Baseline, Day 1 to Day 5
Assessment of separate items of Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
The Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21) Questionnaire is an evaluative illness-specific outcomes instrument designed to assess the severity of cold symptoms and the impact of the common cold (range 0-140), with higher scores indicating more symptoms and functional impairment.
Measured: Baseline, Day 1 to Day 5
Percentage of responders and non-responders to treatment
Percentage of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator will be reported.
Measured: On Day 3, and after the end of treatment on Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start20 Sep 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Why it stopped: Sandoz has decided to withdraw the clinical study due to internal business reasons. No patients were enrolled in any of the participating countries.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070650
- Sponsor's protocol ID
- SAN-0657
- Status last verified
- Aug 2024
- First submitted
- 27 Sep 2021
- Last updated
- 26 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Cold: a Prospective, Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT05070650
- Acronym / sponsor ID
- SAN-0657
- Conditions
- Common Cold
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sandoz has decided to withdraw the clinical study due to internal business reasons. No patients were enrolled in any of the participating countries.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 7 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetylcysteine/Paracetamol/Phenylephrine 200 mg/500 mg/10 mg granules for oral solution | Experimental | Drug: Acetylcysteine, Drug: Paracetamol, Drug: PhenylephrineAcetylcysteine/Paracetamol/Phenylephrine 200 mg/500 mg/10 mg granules for oral solution: one sachet three times per day |
| Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution | Active comparator | Drug: Paracetamol, Drug: PhenylephrineParacetamol/Phenylephrine 500 mg/10 mg granules for oral solution: one sachet three times per day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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):
- Presence of cough with thick mucus production
- Informed consent to participate in the trial provided in written form
Key exclusion criteria (30 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylcysteine200 mg/500 mg/10 mg granules for oral solution: one sachet three times per day | Drug | Acetylcysteine/Paracetamol/Phenylephrine 200 mg/500 mg/10 mg granules for oral solution |
| Paracetamol500 mg/10 mg granules for oral solution: one sachet three times per day | Drug | Acetylcysteine/Paracetamol/Phenylephrine 200 mg/500 mg/10 mg granules for oral solution, Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution |
| Phenylephrine500 mg/10 mg granules for oral solution | Drug | Acetylcysteine/Paracetamol/Phenylephrine 200 mg/500 mg/10 mg granules for oral solution, Paracetamol/Phenylephrine 500 mg/10 mg granules for oral solution |
Primary outcome
Change from baseline in the daily Score of 8 symptoms related to mucus production (SUM8)
Time frame: Baseline, Day 5
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.
7 secondary outcomes
Number of adverse events and serious adverse events
Time frame: Until Day 6, or earlier in case of premature termination
Time to onset of action
Time frame: Day 1 to Day 5
Score of 8 symptoms related to mucus production (SUM8) development over the course of the study
Time frame: Baseline, Day 1 to Day 5
Assessment of separate items of Score of 8 symptoms related to mucus production (SUM8)
Time frame: Baseline, Day 1 to Day 5
Sum of changes from baseline in the daily Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
Time frame: Baseline, Day 1 to Day 5
Assessment of separate items of Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
Time frame: Baseline, Day 1 to Day 5
Percentage of responders and non-responders to treatment
Time frame: On Day 3, and after the end of treatment on Day 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylcysteine, Paracetamol and Phenylephrine in people with Common Cold, run by Sandoz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the daily Score of 8 symptoms related to mucus production (SUM8) (time frame: Baseline, Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2024.