CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 341 enrolled
Drug / intervention
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets +1 moredrug
Likely dose
Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01448057
NCT01448057Phase 3Completed
CompareCT.gov

A Prospective, Randomized, Investigator-Blind Study to Compare Three Days of Treatment With Paracetamol (500 mg) / Dimethindene Maleate (1 mg) / Phenylephrine Hydrochloride (10 mg) Tablets Versus Paracetamol 500 mg Alone in the Treatment of Nasal Congestion and Other Symptoms Due to Cold and Flu

Novartis·interventional·Posted Oct 7, 2011·Updated Mar 3, 2017

In Brief

A Phase 3 clinical trial evaluating Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets and Paracetamol (500 mg) tablets for Upper Respiratory Tract Infection and 3 related conditions. Completed, enrolled 341 participants across 6 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUpper Respiratory Tract Infection, Nasal Congestion, Rhinorrhea, Sneezing
CountriesBrazil
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 7, 2011
Enrollment StartJul 1, 2013
Primary CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.7 years ago

Interventions

Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tabletsdrug

Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets

Paracetamol (500 mg) tabletsdrug

Paracetamol (500 mg) tablets