A Randomized, Double-Blind, Placebo Controlled Cross- Over Study to Investigate the Efficacy and Safety of SC0023, a Magnesium Salt Oral Spray Device, in Adults With Refractory or Unexplained Chronic Cough

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Saudi Arabia
King Saud University Hospital
RECRUITING
Riyadh
Contact Information
Primary
Kholood Altassan
akholood@ksu.edu.sa
+966539703589
Backup
Bashyer Alotaibi
+966552455066
Time Frame
Start Date: 2024-12-19
Estimated Completion Date: 2025-08-30
Participants
Target number of participants: 20
Treatments
Experimental: oral spray of MgCl2
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Kholood Altassan

This content was sourced from clinicaltrials.gov

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