Phase 3
Completed N=272
Phase III Study of ICI35,868 (Diprivan) With and Without EES0000645/A (SDS) on Gastrointestinal Endoscopy
Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy
Source: ClinicalTrials.gov NCT01961349 ↗
Enrolled (actual)
272
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: Achivement of Target Sedation — 21.6; 88.1; 94.5 % of patients — p=<0.001
Summary
This study is designed as a multi-centre, randomised, parallel-group, placebo-controlled, phase III confirmatory study. The study will be partially double-blinded: the comparison between Group 1 (placebo group) and Group 2 (ICI35,868 without EES0000645/A) will be carried out in double-blind, but the comparison between Group 1 (placebo group) and Group 3 (ICI35,868 with EES0000645/A) will be carried out in single-blind.
The efficacy and safety of ICI35,868 with and without EES0000645/A for the sedation to be moderate for a diagnostic gastrointestinal endoscopy and gastrointestinal endoscopic polypectomy will be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Achivement of Target Sedation |
21.6; 88.1; 94.5 | <0.001 sig |
| SECONDARY PSSI Total Score |
65.3; 81.2; 80.8 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
1.Provision of written informed consent prior to any study-related procedures/examinations 2.Aged 20 years and older 3.Subjects who are planned to undergo a non-emergent EGD or colonoscopy, including gastrointestinal endoscopic polypectomy that shall be completed within 1 hour (excluding the endoscopic submucosal dissection and ultrasonic endoscope, pernasal endoscope, etc.). Exclusion Criteria:
- involvement in the planning and/or conduct of the study (applies to both sponsor's employees and/or staffs at the study site)
- Subjects who underwent a endoscopic procedure under ICI35,868 (propofol) administration within 1 year.
- Participation in another clinical study with an investigational product within 4 weeks prior to randomisation.
- Baseline (Visit 1) of blood oxygen saturation (SpO2)<90% (room air)
- ASA III, IV, V and VI ; Subject with serious disease of cardiovascular, respiratory, renal, liver, pancreatic or endocrine function.
Data sourced from ClinicalTrials.gov (NCT01961349). 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.