At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Multi-centre, Randomized, Rater- and Patient-blind, Placebo- and Active-controlled, Parallel Group Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily (Active Test Treatment), Ambroxol Hydrochloride 30 mg Twice Daily (Active Control Treatment) and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions
In Brief
A Phase 3 clinical trial evaluating N-acetylcysteine (NAC) 600 mg, Ambroxol hydrochloride 30 mg, and 1 other intervention for Respiratory Tract Diseases and Abnormal Mucus Secretions. Completed, enrolled 333 participants across 32 sites.
Detailed Summary
This is a phase 3, multicenter, randomized, rater- and patient-blind, placebo- and active-controlled, 3-arm parallel group clinical trial. Patients will be randomized to N-acetylcysteine (NAC) or ambroxol or placebo in a 1:1:1 ratio. A total of approximately 333 patients in China will be randomized. The total study duration will be approximately 8 months including the enrolment period of approximately 7 months and the patient participation duration of 1 month or 4 weeks. Each patient will undergo a screening period of up to 1 week, a 1-week treatment period and a 2-week follow-up period. This study will be conducted in approximately 15-25 sites in China.
Study Details
Timeline
Interventions
NAC will be administered twice a day, morning and evening, during treatment period.
Ambroxol hydrochloride will be administered twice a day, morning and evening, during treatment period.
Placebo will be administered twice a day, morning and evening, during treatment period.