CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 58 enrolled
Drug / intervention
Acetylcystinedrug
Likely dose
Acetylcysteine 2% oral solution (100 mL amber glass bottle, single dose)AI-extracted
Key inclusion· 4
  • ✓Age ≥12 years, male or female
  • ✓Productive cough of less than 7 days duration due to upper respiratory tract infection
  • ✓Cough rated as mild to moderate severity on four-point scale
  • ✓Willingness and ability to comply with study requirements and communicate
Key exclusion· 10
  • ✕Productive cough or sore throat rated as severe pre-dose
  • ✕Pre-dose fever ≥39.4°C measured by oral thermometer
  • ✕Hypersensitivity to acetylcysteine or excipients
  • ✕Pregnant, nursing, or women of childbearing potential not using effective contraception

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

Search/NCT02822287
NCT02822287Phase 3Completed
CompareCT.gov

An Open Label Study to Assess the Warming Sensation, Acceptability and Local Oral Tolerability of NCH-GSK Acetylcysteine 2% Oral Solution, Given as a Single Dose in Subjects Suffering From Productive Cough Due to Upper Respiratory Tract Infection

GlaxoSmithKline·interventional·Posted Jul 4, 2016·Updated Jan 31, 2017

In Brief

A Phase 3 clinical trial evaluating Acetylcystine for Common Cold. Completed, enrolled 58 participants across 1 site.

Detailed Summary

This is a 1-treatment arm, open label design. This 1-day study includes a screening on day of attendance at clinic, followed by a washout period of 30 minutes to 8 hours (if participants are eligible for dosing the same day). The study also includes a supervised dosing with 10 mL oral solution and a 1 hour in-clinic evaluation period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCommon Cold
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 4, 2016
Enrollment StartFeb 1, 2016
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 10.0 years ago

Interventions

Acetylcystinedrug

Clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle.