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Ibuprofen Sodium Dihydrate

Clinical trials investigating Ibuprofen Sodium Dihydrate are studying treatment in patients with symptomatic uncomplicated upper respiratory tract infections with wet cough. The trial data focus on whether the study treatment is effective and safe, and on how quickly symptoms improve. These studies involve adults with upper respiratory tract infections.

Table of Contents

Trial overview

The available trial studied a fixed-dose combination with Ibuprofen Sodium Dihydrate and N-acetylcysteine in patients with symptomatic uncomplicated upper respiratory tract infections with wet cough.[1] The study aimed to test whether the combination worked better than the separate components given alone, and it also looked at safety.[1]

Study design and treatment groups

This was a randomized, multi-centre, double-blind, double-dummy, parallel-group clinical study.[1] In simple terms, people were assigned by chance to different groups, the study was run at more than one center, and neither the patients nor the study team knew which treatment was being used.[1]

The trial compared the fixed-dose combination with its individual components, meaning ibuprofen monotherapy and N-acetylcysteine monotherapy.[1] The trial record also lists matching placebo treatments, which are inactive look-alike products used to keep the study blinded.[1]

Who could participate

The target population was patients with symptomatic uncomplicated upper respiratory tract infections and wet cough.[1] The record does not give more detailed age limits or other eligibility rules in the provided data.[1]

What was measured

The main endpoint was the time from randomization to clinically significant improvement of signs and symptoms of uncomplicated upper respiratory tract infection with wet cough.[1] Improvement was defined as a score of 1 or less on a 5-point Likert scale, where lower scores mean fewer symptoms.[1]

The symptoms assessed were cough, fever, cold symptoms, and the total symptom score.[1] Fever was specifically defined in the trial data as axillary temperature of at least 37.5 °C.[1]

The brief summary says the efficacy goal was to show that 7 days of treatment with the fixed-dose combination was better than the separate components in reaching symptom improvement, and the safety goal was to assess the safety of the investigational products throughout the trial.[1]

Trial status and enrollment

The study was a Phase 3 trial, which is a later-stage study that usually checks how well a treatment works and how safe it is in a larger group of patients.[1] The planned enrollment was 483 participants.[1]

The trial status was Withdrawn, meaning the study was stopped before completion.[1]

Trial ID Phase Condition studied Status Enrollment
2023-505809-17-00 Phase 3 Upper respiratory tract infections with wet cough Withdrawn 483

FAQ

  • What is being studied in trials of Ibuprofen Sodium Dihydrate? The trial is studying whether a treatment that includes Ibuprofen Sodium Dihydrate helps improve symptoms of uncomplicated upper respiratory tract infections with wet cough. It also looks at safety during the study.
  • Who can take part in these trials? The trial data describe patients with symptomatic uncomplicated upper respiratory tract infections and wet cough. The study is designed for people who have these symptoms and meet the trial rules.
  • What phase is the trial? The trial is a Phase 3 study. Phase 3 trials usually look at how well a treatment works and how safe it is in a larger group of patients.
  • What outcomes are the researchers measuring? The main outcome is the time until symptoms improve to a mild level or better. Researchers look at cough, fever, cold symptoms, and the total symptom score.
  • What is the status of the trial? The trial status is Withdrawn. This means the study was stopped before it was completed.

Ongoing Clinical Trials on Ibuprofen Sodium Dihydrate

  • Study on the Effectiveness and Safety of Ibuprofen and N-Acetylcysteine for Patients with Upper Respiratory Tract Infections with Wet Cough

    Not yet recruiting

    3 1 1
    Investigated drugs:
    Italy

Glossary

  • Upper respiratory tract infection (URTI): An infection that affects the nose, throat, and nearby airways. In this trial, it is described as uncomplicated, which means it is not described as having major complications.
  • Wet cough: A cough that brings up mucus or phlegm. This symptom is part of the condition being studied.
  • Randomization: A method of assigning people to study groups by chance, so the groups are more balanced.
  • Double-blind: A study design where neither the patient nor the study team knows which treatment is being given, to reduce bias.
  • Double-dummy: A method used when treatments look different, so everyone takes matching study products and the study stays blinded.
  • Parallel-group: A study design where different groups receive different treatments at the same time.
  • Phase 3: A later stage of clinical testing that usually studies how well a treatment works and how safe it is in more patients.
  • Enrollment: The number of people planned to join the study.
  • Primary outcome: The main result the researchers want to measure to see if the treatment works.
  • Likert scale: A rating scale used to score symptom severity, from no symptom to very severe symptom.

References

  1. https://clinicaltrials.gov/study/2023-505809-17-00