Status:
COMPLETED
A Phase III Study of the Efficacy and Safety of Remimazolam Compared to Placebo and Midazolam in Colonoscopy Patients
Lead Sponsor:
Paion UK Ltd.
Collaborating Sponsors:
Premier Research
Conditions:
Colonoscopy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open-label arm for midazolam, in patient...
Eligibility Criteria
Inclusion
- Male and female patients, aged ≥18, scheduled to undergo a diagnostic or therapeutic colonoscopy (therapeutic procedures could include hemostasis, resection, ablation decompression, foreign body extraction, for example).
- American Society of Anesthesiologists Score 1 through 3
- Body mass index ≤40 kg/m2.
- For female patients with child-bearing potential, negative result of pregnancy test (serum or urine) as well as use of birth control during the study period (from the time of consent until all specified observations were completed).
- Patient voluntarily signed and dated an informed consent form that was approved by an Independent Review Board prior to the conduct of any study procedure.
- Patient was willing and able to comply with study requirements and return for a Follow-up Visit on Day 4 (+3/-1 days) after the colonoscopy.
Exclusion
- Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated.
- Chronic use of benzodiazepines for any indication (eg, insomnia, anxiety, spasticity).
- Chronic use of opioids for any indication.
- Female patients with a positive serum human chorionic gonadotropin pregnancy test at screening or baseline.
- Lactating female patients.
- Patients with positive drugs of abuse screen or a positive serum ethanol at baseline.
- Patient with a history of drug or ethanol abuse within the past 2 years.
- Patients in receipt of any investigational drug within 30 days or less than seven half-lives (whichever was longer) before screening, or scheduled to receive one during the study period.
- Participation in any previous clinical trial with remimazolam.
- Patients with an inability to communicate well in English with the investigator, or deemed unsuitable according to the investigator (in each case providing a reason).
Key Trial Info
Start Date :
March 30 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2016
Estimated Enrollment :
461 Patients enrolled
Trial Details
Trial ID
NCT02290873
Start Date
March 30 2015
End Date
April 19 2016
Last Update
October 20 2020
Active Locations (13)
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1
University of South Alabama
Mobile, Alabama, United States, 36688
2
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
3
Precision Research Institute
Chula Vista, California, United States, 91910
4
Precision Research Institute
San Diego, California, United States, 92114