Phase 2
Completed N=100
Dose-Finding Safety Study Evaluating Remimazolam (CNS 7056) in Patients Undergoing Diagnostic Upper GI Endoscopy
Procedural Sedation · Endoscopy
Source: ClinicalTrials.gov NCT00869440 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Success Rates of the Procedure — 8; 14; 16; 11 Participants
Summary
The purpose of this study was to assess the safety and efficacy of CNS 7056 as a procedural sedative at three dose levels compared to midazolam during a diagnostic upper GI endoscopy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success Rates of the Procedure |
8; 14; 16; 11 | — |
| SECONDARY Time to Fully Alert |
11; 13.4; 12.1; 17.2 | — |
| SECONDARY Time to Ready for Discharge |
14; 12.8; 11.8; 17.2 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients, aged 18 to 65 years inclusive, scheduled to undergo diagnostic upper GI endoscopy.
- American Society of Anesthesiologists Physical Status (ASA PS) Score I or II.
- Weight range 60 to 120 kg inclusive.
- Body mass index (BMI) 18 to 120 kg, or BMI ≥ 30 kg/m2),
- thyro mental distance ≤ 4 cm ("short neck"), or
- Mallampati score of 4 (Appendix IV).
Data sourced from ClinicalTrials.gov (NCT00869440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.