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| ID | Type | Description | Link |
|---|---|---|---|
| B4361001 |
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The objectives of this study are: a) to assess the feasibility and sensitivity of manually count cough bouts over a 4-hour period; b) to assess the effects of buckwheat honey and guaifenesin 400 mg immediate release tablets compared to placebo on the frequency and severity of acute cough due to upper respiratory tract infection and c) to evaluate the correlation between cough bout frequency and subjective assessments of cough severity. The hypotheses to be tested is that 10 ml of buckwheat honey and 400 mg of immediate release guaifenesin will significantly reduce the frequency and severity of cough compared to placebo over a 4-hour evaluation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Guaifenesin | Experimental | Guaifenesin |
|
| Buckwheat Honey | Experimental | Buckwheat Honey |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | One placebo tablet administered orally as a single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cough Bouts Over 4-hour Postdose Period | Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts. | 0 to 4 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Cough Bouts Over 2-hour Postdose Period | Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during first 2 hours postdose. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts. | 0 to 2 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participant With Cough Severity | Participant's self-assessment of cough severity using 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Participants were eligible for study if severity of cough at baseline was at least moderate. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Indianapolis | Indiana | 46240 | United States | ||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Participants stratified by gender and time of dosing (before or at 3:00 pm versus after 3:00 pm).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | One placebo tablet administered orally as a single dose |
| FG001 | Buckwheat Honey | 10 milliliters (mL) administered orally as a single dose |
| FG002 | Guaifenesin | One 400 milligrams (mg) immediate release tablet administered orally as a single dose |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | One placebo tablet administered orally as a single dose |
| BG001 | Buckwheat Honey | 10 milliliters (mL) administered orally as a single dose |
| 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 | Number of Cough Bouts Over 4-hour Postdose Period | Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts. | Intent-to-Treat (ITT) Population: all randomized participants who provided baseline cough counts and were dosed with study product. | Posted | Mean | Standard Deviation | Cough bouts | 0 to 4 hours postdose |
|
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The same event may have appeared as both an adverse event (AE) and a serious adverse event (SAE). However, what was presented were distinct events. An event may have been categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Placebo | One placebo tablet administered orally as a single dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest discomfort | Cardiac disorders | MedDRA (12.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Clinical Trials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquires@Pfizer.com |
Not provided
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006140 | Guaifenesin |
| ID | Term |
|---|---|
| D006139 | Guaiacol |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D010647 |
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| Guaifenesin |
| Drug |
One 400 mg immediate release tablet administered orally as a single dose |
|
| Buckwheat Honey | Other | 10 mL administered orally as a single dose |
|
| Number of Cough Bouts Within Each 15-minute Time Interval Postdose | Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour (240-minute) period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts in 15 minute intervals. | every 15 minutes postdose up to 240 minutes postdose |
| Change From Baseline in Cough Severity Scale | Participant's self-assessment of cough severity using a 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Change from baseline derived by subtracting post baseline cough severity from baseline cough severity. Change from baseline values could have ranged from -1.0 to 3.0 with higher values indicative of greater improvement. | 1, 2, 3, and 4 hours postdose |
| Number of Participants With Global Evaluation of Study Medication | Participant-rated evaluation of study product; Participants responded to the following question: "How would you rate this product as a cough reliever?" 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent | 4 hours postdose or early termination |
| Baseline |
| Lexington |
| Kentucky |
| 40509 |
| United States |
| Ineligible |
|
| Administrative |
|
| BG002 | Guaifenesin | One 400 milligrams (mg) immediate release tablet administered orally as a single dose |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
10 milliliters (mL) administered orally as a single dose
| OG002 | Guaifenesin | One 400 milligrams (mg) immediate release tablet administered orally as a single dose |
|
|
|
| Secondary | Number of Cough Bouts Over 2-hour Postdose Period | Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during first 2 hours postdose. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts. | ITT | Posted | Mean | Standard Deviation | cough bouts | 0 to 2 hours postdose |
|
|
|
|
| Secondary | Number of Cough Bouts Within Each 15-minute Time Interval Postdose | Cough bouts defined as one or several cough sounds occurring after one inspiration (one explosive bout between inspiration and expiration). Audio recordings made of participants during 4-hour (240-minute) period after dosing. Based on audio recordings, a trained cough counter counted and recorded the number of cough bouts in 15 minute intervals. | ITT | Posted | Mean | Standard Deviation | cough bouts | every 15 minutes postdose up to 240 minutes postdose |
|
|
|
|
| Secondary | Change From Baseline in Cough Severity Scale | Participant's self-assessment of cough severity using a 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Change from baseline derived by subtracting post baseline cough severity from baseline cough severity. Change from baseline values could have ranged from -1.0 to 3.0 with higher values indicative of greater improvement. | ITT | Posted | Mean | Standard Deviation | units on a scale | 1, 2, 3, and 4 hours postdose |
|
|
|
|
| Secondary | Number of Participants With Global Evaluation of Study Medication | Participant-rated evaluation of study product; Participants responded to the following question: "How would you rate this product as a cough reliever?" 0=poor, 1=fair, 2=good, 3=very good, and 4=excellent | ITT | Posted | Number | participants | 4 hours postdose or early termination |
|
|
|
|
| Other Pre-specified | Number of Participant With Cough Severity | Participant's self-assessment of cough severity using 4-point categorical scale (0 = none; no cough present, 1 = mild; cough present but with minimal awareness, easily tolerated, 2 = moderate; cough definitely present and bothersome, but tolerable, or 3 = severe; cough was hard to tolerate; may have caused interference with daily activities and sleeping). Participants were eligible for study if severity of cough at baseline was at least moderate. | ITT | Posted | Number | Participants | Baseline |
|
|
|
| 0 |
| 55 |
| 3 |
| 55 |
| EG001 | Buckwheat Honey | 10 milliliters (mL) administered orally as a single dose | 0 | 103 | 3 | 103 |
| EG002 | Guaifenesin | One 400 milligrams (mg) immediate release tablet administered orally as a single dose | 0 | 107 | 4 | 107 |
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Dry throat | Gastrointestinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Feeling jittery | General disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Phenyl Ethers |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
|
Pairwise comparison of number of cough bouts over 2-hour postdose period. |
| Poisson regression model |
| 0.438 |
p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter. |
| Odds Ratio (OR) |
| 0.91 |
| 2-Sided |
| 95 |
| 0.71 |
| 1.16 |
| No |
| Superiority or Other |
| Pairwise comparison of number of cough bouts over 2-hour postdose period. | Poisson regression model | 0.497 | p-values calculated from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site and baseline of cough bouts terms with log(exposure time)as the offset parameter. | Odds Ratio (OR) | 1.08 | 2-Sided | 95 | 0.87 | 1.34 | No | Superiority or Other |
|
| 45 minutes |
|
| 60 minutes |
|
| 75 minutes |
|
| 90 minutes |
|
| 105 minutes |
|
| 120 minutes |
|
| 135 minutes |
|
| 150 minutes |
|
| 165 minutes |
|
| 180 minutes |
|
| 195 minutes |
|
| 210 minutes |
|
| 225 minutes |
|
| 240 minutes |
|
Pairwise comparison of the number of cough bouts within 15 minutes postdose |
| Poisson regression model |
| 0.802 |
p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) |
| Odds Ratio (OR) |
| 0.97 |
| 2-Sided |
| 95 |
| 0.75 |
| 1.25 |
| No |
| Superiority or Other |
| Pairwise comparison of the number of cough bouts within 15 minutes postdose | Poisson regression model | 0.188 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.14 | 2-Sided | 95 | 0.94 | 1.39 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose | Poisson regression model | 0.091 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.78 | 2-Sided | 95 | 0.58 | 1.04 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose | Poisson regression model | 0.465 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.90 | 2-Sided | 95 | 0.69 | 1.19 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 15 and 30 minutes postdose | Poisson regression model | 0.207 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.16 | 2-Sided | 95 | 0.92 | 1.46 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose | Poisson regression model | 0.122 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.81 | 2-Sided | 95 | 0.62 | 1.06 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose | Poisson regression model | 0.165 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.84 | 2-Sided | 95 | 0.66 | 1.07 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 30 and 45 minutes postdose | Poisson regression model | 0.711 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.04 | 2-Sided | 95 | 0.83 | 1.32 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose | Poisson regression model | 0.215 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.84 | 2-Sided | 95 | 0.64 | 1.11 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose | Poisson regression model | 0.367 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.88 | 2-Sided | 95 | 0.67 | 1.16 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 45 and 60 minutes postdose | Poisson regression model | 0.687 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.05 | 2-Sided | 95 | 0.82 | 1.35 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose | Poisson regression model | 0.730 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.94 | 2-Sided | 95 | 0.67 | 1.32 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose | Poisson regression model | 0.923 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.02 | 2-Sided | 95 | 0.74 | 1.39 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 60 and 75 minutes postdose | Poisson regression model | 0.573 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.08 | 2-Sided | 95 | 0.83 | 1.40 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose | Poisson regression model | 0.289 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.84 | 2-Sided | 95 | 0.61 | 1.16 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose | Poisson regression model | 0.379 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.87 | 2-Sided | 95 | 0.64 | 1.18 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 75 and 90 minutes postdose | Poisson regression model | 0.785 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.04 | 2-Sided | 95 | 0.79 | 1.37 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose | Poisson regression model | 0.194 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.82 | 2-Sided | 95 | 0.60 | 1.11 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose | Poisson regression model | 0.212 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.83 | 2-Sided | 95 | 0.62 | 1.11 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 90 and 105 minutes postdose | Poisson regression model | 0.901 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.02 | 2-Sided | 95 | 0.77 | 1.34 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose | Poisson regression model | 0.600 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.93 | 2-Sided | 95 | 0.70 | 1.23 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose | Poisson regression model | 0.853 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.97 | 2-Sided | 95 | 0.74 | 1.29 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 105 and 120 minutes postdose | Poisson regression model | 0.736 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.05 | 2-Sided | 95 | 0.79 | 1.39 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose | Poisson regression model | 0.744 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.95 | 2-Sided | 95 | 0.70 | 1.30 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose | Poisson regression model | 0.904 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.98 | 2-Sided | 95 | 0.72 | 1.33 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 120 and 135 minutes postdose | Poisson regression model | 0.828 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.03 | 2-Sided | 95 | 0.77 | 1.39 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose | Poisson regression model | 0.147 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.80 | 2-Sided | 95 | 0.59 | 1.08 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose | Poisson regression model | 0.345 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.87 | 2-Sided | 95 | 0.65 | 1.16 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 135 and 150 minutes postdose | Poisson regression model | 0.532 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.09 | 2-Sided | 95 | 0.83 | 1.44 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose | Poisson regression model | 0.261 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.83 | 2-Sided | 95 | 0.61 | 1.15 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose | Poisson regression model | 0.601 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.92 | 2-Sided | 95 | 0.69 | 1.24 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 150 and 165 minutes postdose | Poisson regression model | 0.470 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.11 | 2-Sided | 95 | 0.84 | 1.47 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose | Poisson regression model | 0.834 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.97 | 2-Sided | 95 | 0.71 | 1.32 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose | Poisson regression model | 0.628 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.07 | 2-Sided | 95 | 0.81 | 1.43 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 165 and 180 minutes postdose | Poisson regression model | 0.481 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.11 | 2-Sided | 95 | 0.83 | 1.48 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose | Poisson regression model | 0.749 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.94 | 2-Sided | 95 | 0.65 | 1.37 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose | Poisson regression model | 0.857 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.97 | 2-Sided | 95 | 0.70 | 1.35 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 180 and 195 minutes postdose | Poisson regression model | 0.847 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.03 | 2-Sided | 95 | 0.76 | 1.41 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose | Poisson regression model | 0.146 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.77 | 2-Sided | 95 | 0.54 | 1.09 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose | Poisson regression model | 0.702 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.94 | 2-Sided | 95 | 0.69 | 1.29 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 195 and 210 minutes postdose | Poisson regression model | 0.228 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.22 | 2-Sided | 95 | 0.88 | 1.69 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose | Poisson regression model | 0.130 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.75 | 2-Sided | 95 | 0.51 | 1.09 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose | Poisson regression model | 0.371 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.85 | 2-Sided | 95 | 0.60 | 1.21 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 210 and 225 minutes postdose | Poisson regression model | 0.430 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.14 | 2-Sided | 95 | 0.82 | 1.58 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose | Poisson regression model | 0.177 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.76 | 2-Sided | 95 | 0.51 | 1.13 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose | Poisson regression model | 0.580 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 0.91 | 2-Sided | 95 | 0.64 | 1.28 | No | Superiority or Other |
| Pairwise comparison of the number of cough bouts between 225 and 240 minutes postdose | Poisson regression model | 0.333 | p-values from Poisson regression model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), site, and baseline of cough bouts terms with log(exposure time) | Odds Ratio (OR) | 1.19 | 2-Sided | 95 | 0.84 | 1.70 | No | Superiority or Other |
|
| 3 hours postdose |
|
| 4 hours postdose |
|
Pairwise comparison of change from baseline in cough severity at 1 hour postdose |
| ANOVA |
| 0.737 |
p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms. |
| Mean Difference (Final Values) |
| -0.03 |
| 2-Sided |
| 95 |
| -0.20 |
| 0.14 |
| No |
| Superiority or Other |
| Pairwise comparison of change from baseline in cough severity at 1 hour postdose | ANOVA | 0.078 | p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms. | Mean Difference (Final Values) | -0.13 | 2-Sided | 95 | -0.27 | 0.01 | No | Superiority or Other |
| Pairwise comparison of change from baseline in cough severity at 2 hour postdose | ANOVA | 0.125 | p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms. | Mean Difference (Final Values) | 0.16 | 2-Sided | 95 | -0.04 | 0.36 | No | Superiority or Other |
| Pairwise comparison of change from baseline in cough severity at 2 hour postdose | ANOVA | 0.688 | p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms. | Mean Difference (Final Values) | 0.04 | 2-Sided | 95 | -0.16 | 0.24 | No | Superiority or Other |
| Pairwise comparison of change from baseline in cough severity at 2 hour postdose | ANOVA | 0.166 | p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms. | Mean Difference (Final Values) | -0.12 | 2-Sided | 95 | -0.29 | 0.05 | No | Superiority or Other |
| Pairwise comparison of change from baseline in cough severity at 3 hour postdose | ANOVA | 0.233 | p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms. | Mean Difference (Final Values) | 0.13 | 2-Sided | 95 | -0.09 | 0.35 | No | Superiority or Other |
| Pairwise comparison of change from baseline in cough severity at 3 hour postdose | ANOVA | 0.848 | p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms. | Mean Difference (Final Values) | -0.02 | 2-Sided | 95 | -0.24 | 0.19 | No | Superiority or Other |
| Pairwise comparison of change from baseline in cough severity at 3 hour postdose | ANOVA | 0.093 | p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms. | Mean Difference (Final Values) | -0.15 | 2-Sided | 95 | -0.33 | 0.03 | No | Superiority or Other |
| Pairwise comparison of change from baseline in cough severity at 4 hour postdose | ANOVA | 0.406 | p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms. | Mean Difference (Final Values) | 0.10 | 2-Sided | 95 | -0.14 | 0.34 | No | Superiority or Other |
| Pairwise comparison of change from baseline in cough severity at 4 hour postdose | ANOVA | 0.991 | p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms. | Mean Difference (Final Values) | -0.00 | 2-Sided | 95 | -0.24 | 0.24 | No | Superiority or Other |
| Pairwise comparison of change from baseline in cough severity at 4 hour postdose | ANOVA | 0.306 | p-values from ANOVA model with treatment, gender, time stratum (dosing before or at 3:00 pm, or after 3:00 pm), and site terms. | Mean Difference (Final Values) | -0.10 | 2-Sided | 95 | -0.30 | 0.09 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Good |
|
| Very Good |
|
| Excellent |
|
Pairwise comparison of global evaluation of study medication. |
| Cochran-Mantel-Haenszel |
| 0.949 |
p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site. |
| weighted Goodman-Kruskal Gamma statistic |
| -0.01 |
| 2-Sided |
| 95 |
| -0.25 |
| 0.23 |
| No |
| Superiority or Other |
| Pairwise comparison of global evaluation of study medication. | Cochran-Mantel-Haenszel | 0.256 | p-values from Cochran-Mantel-Haenszel test with modified ridit scores, controlling for gender, time stratum, and site. | weighted Goodman-Kruskal Gamma statistic | -0.12 | 2-Sided | 95 | -0.32 | 0.08 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|