Trials / Terminated
TerminatedNCT01257542
Acute Cough Study In Children
A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Single-Dose, Pilot Study To Evaluate Efficacy Of Dextromethorphan Hydrobromide On Acute Cough In A Pediatric Population
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 140 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 6 Years – 11 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dextromethorphan | A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg) |
| DRUG | Placebo | A single 10 mL dose of matching placebo syrup |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2011-03-01
- Completion
- 2011-03-01
- First posted
- 2010-12-09
- Last updated
- 2012-09-20
- Results posted
- 2012-09-20
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01257542. Inclusion in this directory is not an endorsement.