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This study is designed to improve knowledge regarding the initial effectiveness of N-acetylcysteine (NAC) on cold and cough symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A N-acetylcysteine | Experimental | N-acetylcysteine |
|
| B Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours) | Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Daily Dose of NAC (Number of Patients With Adverse Advents) | Number of patients with adverse advents | 7 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicoutimi | Quebec | Canada | ||||
Screening and randomization are on day 1 Duration of the study = 7 days
8 centers in canada Start date 26 Jan 2015 End date 01 Apr 2015
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| ID | Title | Description |
|---|---|---|
| FG000 | A N-acetylcysteine | N-acetylcysteine N-acetylcysteine, capsules, 800 mg 3 times daily |
| FG001 | B Placebo | Placebo Placebo, matching capsules three times daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A N-acetylcysteine | N-acetylcysteine N-acetylcysteine |
| BG001 | B Placebo | Placebo Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cough Count (Number of Coughs Will be Measured by a 24-hour Ambulatory Cough Monitoring System for the First 72 Hours) | Number of coughs will be measured by a 24-hour ambulatory cough monitoring system for the first 72 hours | Full Analysis set | Posted | Mean | Standard Deviation | log-transformed total cough count | 72 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A N-acetylcysteine | N-acetylcysteine N-acetylcysteine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Marianna Armogida Director Clinical Research Innovation | Novartis | +41223635182 | marianna.armogida@novartis.com |
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| ID | Term |
|---|---|
| D003371 | Cough |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Montreal |
| Quebec |
| Canada |
| Québec | Quebec | Canada |
| Sherbrook | Quebec | Canada |
| Victoriaville | Quebec | Canada |
| Withdrawal by Subject |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Safety of Daily Dose of NAC (Number of Patients With Adverse Advents) | Number of patients with adverse advents | Posted | Number | participants | 7 Days |
|
|
|
| 0 |
| 35 |
| 2 |
| 35 |
| EG001 | B Placebo | Placebo Placebo | 0 | 35 | 2 | 35 |
Sponsor shall review results communications prior to public release to evaluate the manuscript for accuracy, ascertain whether information (other than the results of the Clinical Trial) is being improperly disclosed, provided information which may have not have yet been made available by the Sponsor, provide input for consideration regarding the content and/or conclusion(s) of the manuscript and determine whether the manuscript discloses any potentially patentable invention(s).
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |