Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| RB-10-12 |
Not provided
Not provided
Not provided
See termination reason in detailed description.
Not provided
| Name | Class |
|---|---|
| AccuDial Pharmaceutical, Inc. | OTHER |
| Boehringer Ingelheim | INDUSTRY |
| McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. | INDUSTRY |
| Novartis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
15 mg dextromethorphan hydrobromide will be better than placebo with respect to reducing the number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.
In light of protocol changes required due to methodological and operational issues, including background noise in cough recordings which could impact data interpretation, the study has been terminated.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextromethorphan | Drug | A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Cough Count | Total cough count was done by trained assessors using continuous digital video and audio recordings. | Up to 6 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period | Perceived verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline over the 6-hour post-dosing period calculated as the average of change from baseline [that is (i.e.) baseline value minus the post baseline value] measurements of Hour 1 to Hour 6, thus the change from baseline ranged from -4 to 4; higher score indicated a better improvement. |
Not provided
Inclusion Criteria:
Male or female healthy children ages 6 to under 12 years who are symptomatic with a cough due to a cold or acute URTI characterized by:
General good health, aside from a common cold, and has no contraindications to the study or rescue medication
Exclusion Criteria:
History of clinically significant cardiovascular, pulmonary, hepatic, renal, neurological, hematological, autoimmune, psychiatric, metabolic, gastro-intestinal or endocrine disease
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DMI Research | Pinellas Park | Florida | 33782-4533 | United States | ||
| Concentrics Center for Research |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide. |
| FG001 | Dextromethorphan Hydrobromide | Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)]. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide. |
| BG001 | Dextromethorphan Hydrobromide | Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)]. |
| 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 | Total Cough Count | Total cough count was done by trained assessors using continuous digital video and audio recordings. | Intent-to-treat (ITT) population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment. | Posted | Mean | Standard Deviation | Cough counts | Up to 6 hours post-dose |
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be 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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
Due to methodological issues during study conduct, the study was terminated after only less than 50% of the targeted enrollment was achieved.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D003139 | Common Cold |
| D012141 | Respiratory Tract Infections |
| D003371 | Cough |
| ID | Term |
|---|---|
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003915 | Dextromethorphan |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| INDUSTRY |
| Perrigo Company | INDUSTRY |
| Procter and Gamble | INDUSTRY |
| Reckitt Benckiser LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | A single 10 mL dose of matching placebo syrup |
|
| Baseline, 1, 2, 3, 4, 5, 6 hours post-dose |
| Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6 | Verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline values were derived by subtracting each post baseline value from the baseline value, and ranged from -4 to 4; higher score indicated a better improvement. | Baseline, 1, 2, 3, 4, 5, 6 hours |
| Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period | Perceived numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = did not cough at all and 10 = cough a lot. The change from baseline for the 6-hour post-dosing period was calculated as the average of change from baseline (i.e. baseline value minus the post baseline value) measurements of Hour 1 to Hour 6, thus the change from baseline values ranged from -10 to 10; higher score indicated a better improvement. | Baseline, 1, 2, 3, 4, 5, 6 hour post-dose |
| Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6 | Numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", wherein 0 = did not cough at all and 10 = cough a lot. The change from baseline was derived by subtracting the post baseline value from the baseline value and ranged from -10 to 10; higher score indicated a better improvement. | Baseline, 1, 2, 3, 4, 5, 6 hours |
| Participants' Global Assessment of Cough: Cough Severity | Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question " How much have you coughed in the past 6 hours?" where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. | Within 5 minutes after Hour 6 |
| Participants' Global Assessment of Cough: Relief From Cough | Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question "From when you woke up this morning until now, how much better is your cough?" where 0 = not at all better, 1 = a tiny bit better, 2 = a little better, 3 = better and 4 = a lot better. | Within 5 minutes after Hour 6 |
| Indianapolis |
| Indiana |
| 46240 |
| United States |
| Cyn3rgy Research | Gresham | Oregon | 97030 | United States |
| Clinical Research Associates Incorporated | Nashville | Tennessee | 37203 | United States |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Change From Baseline in Perceived Verbal Cough Severity Scale for 6 Hour Post-Dose Period | Perceived verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline over the 6-hour post-dosing period calculated as the average of change from baseline [that is (i.e.) baseline value minus the post baseline value] measurements of Hour 1 to Hour 6, thus the change from baseline ranged from -4 to 4; higher score indicated a better improvement. | ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 1, 2, 3, 4, 5, 6 hours post-dose |
|
|
|
|
| Secondary | Change From Baseline in Verbal Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6 | Verbal cough severity score was assessed on a 5-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. The change from baseline values were derived by subtracting each post baseline value from the baseline value, and ranged from -4 to 4; higher score indicated a better improvement. | ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 1, 2, 3, 4, 5, 6 hours |
|
|
|
|
| Secondary | Change From Baseline in Perceived Numerical Cough Severity Scale for 6 Hour Post-Dose Period | Perceived numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", where 0 = did not cough at all and 10 = cough a lot. The change from baseline for the 6-hour post-dosing period was calculated as the average of change from baseline (i.e. baseline value minus the post baseline value) measurements of Hour 1 to Hour 6, thus the change from baseline values ranged from -10 to 10; higher score indicated a better improvement. | ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 1, 2, 3, 4, 5, 6 hour post-dose |
|
|
|
|
| Secondary | Change From Baseline in Numerical Cough Severity Scale at Hours 1, 2, 3, 4, 5 and 6 | Numerical cough severity score was assessed on an 11-point categorical rating scale in accordance to the question "How much have you coughed in the last hour?", wherein 0 = did not cough at all and 10 = cough a lot. The change from baseline was derived by subtracting the post baseline value from the baseline value and ranged from -10 to 10; higher score indicated a better improvement. | ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 1, 2, 3, 4, 5, 6 hours |
|
|
|
|
| Secondary | Participants' Global Assessment of Cough: Cough Severity | Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question " How much have you coughed in the past 6 hours?" where 0 = not at all, 1 = a tiny bit, 2 = a little, 3 = some and 4 = a lot. | ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment. | Posted | Mean | Standard Deviation | Units on a scale | Within 5 minutes after Hour 6 |
|
|
|
|
| Secondary | Participants' Global Assessment of Cough: Relief From Cough | Participant global assessment of cough with the assistance of parent or legal guardian was scored on a 5-point categorical scale based on response to the question "From when you woke up this morning until now, how much better is your cough?" where 0 = not at all better, 1 = a tiny bit better, 2 = a little better, 3 = better and 4 = a lot better. | ITT population included all randomized participants who received study medication, provided baseline efficacy data and any post baseline assessment. | Posted | Mean | Standard Deviation | Units on a scale | Within 5 minutes after Hour 6 |
|
|
|
|
| 0 |
| 55 |
| 4 |
| 55 |
| EG001 | Dextromethorphan Hydrobromide | Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)]. | 0 | 52 | 6 | 52 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v13.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v13.0 | Non-systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | 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.
| D012140 |
| Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Change at 3 hours |
|
| Change at 4 hours |
|
| Change at 5 hours |
|
| Change at 6 hours |
|
2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model. |
| ANOVA |
| 0.358 |
p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms. |
| LS mean difference |
| -0.20 |
| 2-Sided |
| 95 |
| -0.64 |
| 0.23 |
| No |
| Superiority or Other |
| 3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model. | ANOVA | 0.139 | p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms. | LS mean difference | -0.32 | 2-Sided | 95 | -0.74 | 0.10 | No | Superiority or Other |
| 4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model. | ANOVA | 0.364 | p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms. | LS mean difference | -0.21 | 2-Sided | 95 | -0.68 | 0.25 | No | Superiority or Other |
| 5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model. | ANOVA | 0.039 | p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms. | LS mean difference | -0.46 | 2-Sided | 95 | -0.90 | -0.02 | No | Superiority or Other |
| 6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model. | ANOVA | 0.206 | p-value was calculated using ANOVA model with treatment, site and baseline cough severity verbal rating scale terms. | LS mean difference | -0.29 | 2-Sided | 95 | -0.75 | 0.16 | No | Superiority or Other |
| Change at 3 hours |
|
| Change at 4 hours |
|
| Change at 5 hours |
|
| Change at 6 hours |
|
2 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model. |
| ANOVA |
| 0.426 |
p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms. |
| LS mean difference |
| -0.44 |
| 2-Sided |
| 95 |
| -1.54 |
| 0.65 |
| No |
| Superiority or Other |
| 3 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model. | ANOVA | 0.396 | p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms. | LS mean difference | -0.45 | 2-Sided | 95 | -1.49 | 0.60 | No | Superiority or Other |
| 4 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model. | ANOVA | 0.402 | p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms. | LS mean difference | -0.49 | 2-Sided | 95 | -1.63 | 0.66 | No | Superiority or Other |
| 5 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model. | ANOVA | 0.204 | p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms. | LS mean difference | -0.69 | 2-Sided | 95 | -1.75 | 0.38 | No | Superiority or Other |
| 6 hours: treatment difference and corresponding 95% CI were calculated based on LS means from ANOVA model. | ANOVA | 0.179 | p-value was calculated using ANOVA model with treatment, site and baseline cough severity numerical rating scale terms. | LS mean difference | -0.84 | 2-Sided | 95 | -2.06 | 0.39 | No | Superiority or Other |