Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE4
140 participants
INTERVENTIONAL
2010-12-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active
Dextromethorphan
A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg)
Placebo
Placebo
A single 10 mL dose of matching placebo syrup
Interventions
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Dextromethorphan
A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg)
Placebo
A single 10 mL dose of matching placebo syrup
Eligibility Criteria
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Inclusion Criteria
* Onset of cold/URTI symptoms occurring no more than 10 days prior to Visit 1;
* At least 5 coughs during the second 30-minute period of the 60-minute baseline period.
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
6 Years
11 Years
ALL
No
Sponsors
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AccuDial Pharmaceutical, Inc.
OTHER
Boehringer Ingelheim
INDUSTRY
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
INDUSTRY
Novartis
INDUSTRY
Perrigo Company
INDUSTRY
Procter and Gamble
INDUSTRY
Reckitt Benckiser LLC
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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DMI Research
Pinellas Park, Florida, United States
Concentrics Center for Research
Indianapolis, Indiana, United States
Cyn3rgy Research
Gresham, Oregon, United States
Clinical Research Associates Incorporated
Nashville, Tennessee, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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RB-10-12
Identifier Type: -
Identifier Source: secondary_id
A6531001
Identifier Type: -
Identifier Source: org_study_id