Dose Rate Range Finding Study of Propofol for minimal-to Moderate Sedation on Upper & Lower Endoscopic Tests

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Gastrointestinal Endoscopy; Gastrointestinal Polypectomy

Treatments: Drug: Placebo; Drug: ICI35,868 (propofol)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01189604

D0092C00001

Details and patient eligibility

About

Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.

Enrollment: 123 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female (females of child bearing potential to confirm not pregnant via test or contraception)
• Be undergoing a non-emergent esophagogastroduodenoscopy (EGD) or colonoscopy, including polypectomy that shall be completed within 1 hour

Exclusion criteria

• American Society of Anesthesiologists (ASA) grade III, IV V and VI
• Baseline oxygen saturation<90% (room air)
• Body Mass Index (BMI) >=35

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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123 participants in 7 patient groups, including a placebo group

Arm1 - Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Arm 2 - ICI35,868 (propofol)

Active Comparator group

Treatment:

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Arm 3 - ICI35,868 (propofol)

Active Comparator group

Treatment:

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Arm 4 - ICI35,868 (propofol)

Active Comparator group

Treatment:

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Arm 5 - ICI35,868 (propofol)

Active Comparator group

Treatment:

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Arm 6 - ICI35,868 (propofol)

Active Comparator group

Treatment:

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Arm 7 - ICI35,868 (propofol)

Active Comparator group

Treatment:

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)

Drug: ICI35,868 (propofol)