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A Randomized, Double-blind, Cross-over Study of S-600918 in Participants with Sleep Apnea Syndrome

Phase 2
Completed
Conditions
Sleep Apnea Syndrome
Registration Number
JPRN-jRCT2080225317
Lead Sponsor
SHIONOGI & CO., LTD.
Brief Summary

o obvious improvement in the primary endpoint of the change in AHI at Day 7 from baseline was found after administration of S-600918 300 mg compared with placebo, and the difference between the study drugs was not statistically significant. S-600918 was generally safe and well tolerated at a once daily dose of 300 mg for 7 days.

Detailed Description

Not available

Recruitment & Eligibility

Status
completed
Sex
All
Target Recruitment
33
Inclusion Criteria

Key Inclusion Criteria:
- Participants diagnosed with sleep apnea syndrome or suspected sleep apnea based on the International Classification of Sleep Disorders, Third Edition (ICSD-3).

Exclusion Criteria

Key Exclusion Criteria:
- Participants with a clinically significant active respiratory disease.
- Participants with obvious morphological abnormalities of the upper respiratory tract, micrognathia, or developmental failure of the mandible.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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