A Study Evaluating the Safety and Efficacy of Remimazolam (CNS 7056) Compared to Placebo and Midazolam in ASA III and IV Patients Undergoing Colonoscopy
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- STATUS
- Recruiting
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- sponsor
- Paion UK Limited
Summary
A Study Evaluating the Safety and Efficacy of Remimazolam (CNS 7056) Compared to Placebo and Midazolam in ASA III and IV Patients Undergoing Colonoscopy
Description
This is a sedation during colonoscopy study. The primary objective of this study is to assess the safety of multiple doses (initial dose and additional top-up doses) of remimazolam compared to placebo and midazolam, following administration of a standard dose of fentanyl.
Procedural sedation in adult patients undergoing colonoscopy for diagnostic or therapeutic purposes. Includes the collection of blood and urine samples, ECGs, and questionnaires, in addition to already scheduled colonoscopy. All participants will receive sedation for the colonoscopy by study drug or by FDA approved medication.
A total of 3 clinic/research visits and one telephone follow up call to each participant.
Details
| Condition | Colon Cancer Screening |
|---|---|
| Clinical Study Identifier | TX141709 |
| Sponsor | Paion UK Limited |
| Last Modified on | 8 November 2020 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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