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Fixed-dose Combination of 1000 mg Dipyrone Monohydrate + 60 mg Caffeine + 4 mg Chlorpheniramine Maleate in Improving Symptoms of the Common Cold and Flu in Adults

NCT07626437 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2026-06-16

No results posted yet for this study

Summary

Phase III clinical trial to evaluate the efficacy and safety of a fixed-dose combination of 1000 mg dipyrone monohydrate + 60 mg caffeine + 4 mg chlorpheniramine maleate in improving symptoms of the common cold and flu in adults.

Conditions

  • Common Cold/Flu
  • Nasal Congestion
  • Nasal Obstruction

Interventions

DRUG

dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg

The differential of this study is the dosages and reduction of doses per day.

DRUG

dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg

The differential of this intervention is the dosages

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Brainfarma Industria Química e Farmacêutica S/A

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-08
Primary Completion
2027-06-28
Completion
2027-06-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07626437 on ClinicalTrials.gov