A Study Evaluating Tolerability, Efficacy, and Safety of HSK3486 Injectable Emulsion in Patients

Colonoscopy Clinical Trial

Official title:

A Phase IIa, Multi-center, Open-label, Non-randomized, Active-controlled, and Dose-escalation Clinical Study Evaluating Tolerability, Efficacy, and Safety of HSK3486 Injectable Emulsion for Sedation/Anesthesia in Patients Undergoing Diagnostic Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773042
• Other study ID #: HSK3486-201
• Status: Completed
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Sichuan Haisco Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A double-blind, randomized, active controlled, multi-center, parallel group study comparing HSK3486 with Propofol, in patients undergoing a colonoscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria (those who meet all of the following are eligible)

1. Patients requiring diagnostic colonoscopy with an estimated examination time = 30 min; males and females, ASA grade I-II, between 18 and 65 years old (inclusive);

2. Body mass index (BMI) = 18 and = 30 kg/m2

3. Respiratory rate between = 10 and = 24 breaths per minute; SpO2 when inhaling > 95%; SBP = 90 mmHg; DBP = 60 mmHg; heart rate between = 50 and = 100 beats per minute;

4. Subjects must understand the procedures and methods of this study, and be willing to provide informed consent and to complete the trial in strict accordance with clinical trial protocol.

Exclusion Criteria (those who meet any one of the following are ineligible):

1. Patients having contraindications to general anesthesia or previous history of anesthesia accidents;

2. Patients with a known sensitivity to propofol, opioids, naloxone, eggs, soy products or a medical condition such that these agents were contraindicated;

3. Patient received any of the following drugs or therapies prior to screening:

1. Participated in other drug clinical trials within 3 month prior to screening;

2. In receipt of propofol and/or opioid analgesics within 1 month prior to screening;

4. The patient has some history or evidence of increased risk of sedation or anesthesia, such as cardiovascular disease, respiratory disease, cerebrovascular disease, gastrodintestinal disease and other system disease prior to the screening and/or baseline period.

5. Patient whose laboratory parameters measured at screening/prior to enrollment reach the following criteria and verified through re-examinations:

1. ANC = 1.5 x 109/L;

2. PLT = 80 x 109/L;

3. Hb = 90 g/L (no blood transfusion within the last 14 days);

4. AST and ALT = 2.5 x ULN;

5. TBIL = 1.5 x ULN;

6. Creatinine = 1.5 x ULN.

6. History of alcohol abuse within 3 months prior to screening or with a positive result of alcohol saliva strip test (before dose);

7. History of medication abuse within 3 months prior to screening, or a positive urine medication test (during screening or before dose administration);

8. Women who are pregnant or breastfeeding; women of child-bearing potential or men who are unwilling to use contraception during the trial; Patients who are planning pregnancy within 1 month after the completion of the trial (including male patients);

9. Potential difficult airway or difficult tracheal intubation, as determined by the investigator, and/or history of intubation failure;

10. Patients determined by the investigator to be unsuitable for participating in this trial for any reason.

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• HSK3486
For induction and maintenance of sedation.
• Propofol
For induction and maintenance of sedation.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Haisco Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of successful colonoscopies.		From the first dose of the study drug to removal of colonoscope on day 1
Secondary	Insertion time		From the first dose of study drug until insertion of colonoscope on day 1
Secondary	The success rate of the colonoscopy procedure	The number of patients who successfully completed the colonoscopy procedure accounted for the proportion of all patients in the dose group	From the first dose of the study drug to removal of colonoscope on day 1
Secondary	Time to fully alert		From the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 5 on day 1
Secondary	Time to discharge		From the removal of colonoscopy procedure, until the first of three consecutive MOAA/S scores of 9 on day 1
Secondary	Application of study drug and alternative medication	Total dosages of study drug and alternative medication	During the colonoscopy procedure on day 1
Secondary	Mini-Mental State Examinations (MMSE)		During the screening and the colonoscopy procedure on day 1