Study to Investigate the Efficacy and Safety of SC0023, in Adults With Refractory or Unexplained … (NCT07003347) | Clinical Trial Compass
CompletedNot Applicable
Study to Investigate the Efficacy and Safety of SC0023, in Adults With Refractory or Unexplained Chronic Cough
Saudi Arabia7 participantsStarted 2024-12-19
Plain-language summary
This is a randomized, double-blind, placebo controlled cross-over study to investigate the efficacy and safety of SC0023 (an oral spray of magnesium based alkaline hypertonic divalent salt) in adults with refractory or unexplained chronic cough over 14 days.
Approximately 20 participants being enrolled and randomized into the study.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Males and females between 18-80 years
* Capable of giving signed informed consent
* Diagnosed with RCC (including unexplained chronic cough) for at least 6 months and at least 4 coughs per hour on average during awake hours at Screening.
* Score ≥ 40 mm on cough severity VAS at screening.
* Normal FEV/FVC
* Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose.
Exclusion Criteria:
* Current smoker/vaper (all forms of smoking and inhaled substances, including, cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history.
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma.
* Respiratory tract infection within 4 weeks before screening.
* History of malignancy in the last 5 years.
* History of alcohol or drug abuse within the last 3 years.
* Opioid use in last 7 days of screening.
* History of a positive serologic test for, hepatitis B virus surface antigen, or hepatitis C virus.
* Previous participation in clinical trial in last 30 days or 6-half lives of test drug activity.
* Use of prohibited medications anti-tussive therapy, gabapentin, pregabalin, baclofen, tricyclics, systemic corticosteroids, ACE inhibitors, beta blockers.
* Use of dietary supplements containing magnesium for the duration o…