Phase 3
N=341
Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu
Upper Respiratory Tract Infection · Nasal Congestion · Rhinorrhea · Sneezing
Bottom Line
View on ClinicalTrials.gov: NCT01448057 ↗Enrolled (actual)
341
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Physician Global Evaluation of Effectiveness on Nasal Symptoms — 1.9; 2.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets (Drug); Paracetamol (500 mg) tablets (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physician Global Evaluation of Effectiveness on Nasal Symptoms |
1.9; 2.1 | — |
| SECONDARY Daily Average of the Sum of a 100 mm Visual Analog Scale for All Symptoms |
169.2; 225.3 | — |
Summary
The study is a clinical evaluation of an over the counter (OTC) combination product containing paracetamol (500 mg), dimethindene maleate (1 mg), phenylephrine hydrochloride (10 mg) compared to paracetamol (500 mg) alone in the treatment of nasal congestion, rhinorrhea, sneezing and other symptoms due to upper respiratory tract infection (URTI).
Eligibility Criteria
- Inclusion criteria:
- acute URTI, diagnosed by a health care professional at the study site, with the following symptoms having started within 72 hours before the screening/baseline Visit: nasal congestion, sneezing, and rhinorrhea.
- Exclusion criteria:
- Use of other investigational drugs within 30 days or 10 half-lives before enrollment, whichever is longer.
- History of or known hypersensitivity to any of the study drugs, excipients or to drugs of similar chemical classes.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01448057). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.