NCT01158326

Evaluation of Efficacy and Safety of Oral Solution Paracetamol, Maleate Chlorpheniramine and Phenylephrine Hydrochloride in Reducing Symptoms of Common Cold and Flu: a Double-blind

Completed Phase 3 Last updated 24 November 2011

What this trial tests

Phase 3 trial testing Resfenol in Common Cold in 216 participants. Completed in 1 November 2011.

Timeline

1 August 2010

Primary endpoint
1 September 2011

1 November 2011

Quick facts

Lead sponsor	Hospital de Clinicas de Porto Alegre
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	216
Start date	1 August 2010
Primary completion	1 September 2011
Estimated completion	1 November 2011
Sites	1 location across Brazil

Drugs / interventions tested

• Resfenol — full drug profile →
• Placebo

Conditions studied

• Common Cold — all drugs for Common Cold →
• Influenza — all drugs for Influenza →

Sponsor

Hospital de Clinicas de Porto Alegre

Who can join

Adults 12 to 60, any sex, with Common Cold or Influenza. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Reduction global symptom score (0-none, 1-weak, 2-medium, 3-strong)
  Time frame: 48 hours
  emergence of adverse events

Sponsor's own description

This study aimed to evaluate the efficacy and safety of the oral solution of paracetamol, chlorpheniramine maleate and phenylephrine hydrochloride in reducing symptoms of flu and the common cold. There will be a randomized, double-blind, placebo-controlled trial. Will be included 216 subjects, male or female, aged greater than 12 and less than or equal to 60 years, irrespective of color and / or race with symptoms of recent onset, for more than 6 hours and less than 48 hours length, characterizing Common Cold and / or Influenza.

After clinical evaluation and laboratory research subjects will be randomized to receive active drug or placebo, 10 ml oral solution every 6 hours for 48 hours. The follow-up visits will be held on 2 (24 hours after first intervention) and in 3 days (48 hours after first intervention).

The outcomes to assess the effectiveness so far consist of the scores of symptoms and to assess the safety of the drug will be accompanied by the emergence of adverse events.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.