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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    Paion UK Limited
Updated on 8 November 2020


A Study Evaluating the Safety and Efficacy of Remimazolam (CNS 7056) Compared to Placebo and Midazolam in ASA III and IV Patients Undergoing Colonoscopy


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.

Condition Colon Cancer Screening
Clinical Study IdentifierTX141709
SponsorPaion UK Limited
Last Modified on8 November 2020


Yes No Not Sure

Inclusion Criteria

Scheduled to undergo colonoscopy

Exclusion Criteria

Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents are contraindicated
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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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete 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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