Evaluation of Efficacy and Safety of Tablets of Paracetamol, Dimethindene Maleate and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu

Novartis

Status and phase: Completed; Phase 3

Conditions: Rhinorrhea; Sneezing; Nasal Congestion; Upper Respiratory Tract Infection

Treatments: Drug: Paracetamol (500 mg) tablets; Drug: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT01448057

381-A-301

Details and patient eligibility

About

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).

Enrollment: 341 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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341 participants in 2 patient groups

Combination Product

Experimental group

Description:

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

Treatment:

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

Paracetamol tablets

Active Comparator group

Description:

Paracetamol (500 mg) tablets

Treatment:

Drug: Paracetamol (500 mg) tablets