Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy Clinical Trial
— Kagami_SDSOfficial title:
A Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase III Confirmatory Study to Assess Efficacy and Safety of the Moderate Sedation of ICI35,868 With and Without EES0000645/A on Gastrointestinal Endoscopy
| Verified date | October 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Pharmaceutical and Medical Devices Agency |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 279 |
| Est. completion date | March 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
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: 1. involvement in the planning and/or conduct of the study (applies to both sponsor's employees and/or staffs at the study site) 2. Subjects who underwent a endoscopic procedure under ICI35,868 (propofol) administration within 1 year. 3. Participation in another clinical study with an investigational product within 4 weeks prior to randomisation. 4. Baseline (Visit 1) of blood oxygen saturation (SpO2)<90% (room air) 5. ASA III, IV, V and VI ; Subject with serious disease of cardiovascular, respiratory, renal, liver, pancreatic or endocrine function. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Research Site | Moriya-shi | |
| Japan | Research Site | Shinjuku-ku | |
| Japan | Research Site | Yokohama-shi |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca | Johnson & Johnson |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Achivement of Target Sedation | The target sedation is defined as MOAA/S (Modified Observer's Assessment of Alertness/Sedation) scores 2 to 4 for =50% of all MOAA/S measurements from scope-in to scope-out. | from scope-in to scope-out | No |
| Secondary | PSSI Total Score | PSSI (Statistics of Patient Satisfaction with Sedation Instrument) total score obtained from 20 questions (1 to 7 points for each) adjusted to have range of 0 ( very dissatisfied: all items scored with 1 point) to 100 (very satisfied: all items scored with 7 points) | at 24-48 h after endoscopy | No |