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GastroscopyPhase 2NCT06682546

A Trial to Evaluate the Efficacy and Safety of Methoxyethyl Etomidate Hydrochloride in Gastroscopy/Colonoscopy

A Phase 2 study testing ET-26HCl 0.6mg/kg group, ET-26HCl 0.8mg/kg group and Etomidate Injectable Product 0.3mg/kg group in people with Gastroscopy and Colonoscopy, run by Ahon Pharmaceutical Co., Ltd. at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A total of 78 subjects undergoing gastroscopy/colonoscopy were randomly assigned to the methoxetomidate hydrochloride group and the etomidate group according to the ratio of 1:1:1 with etomidate as the control group, 26 cases in each group. All subjects were blinded to treatment allocation. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastroscopy, Colonoscopy
What is being tested?
ET-26HCl 0.6mg/kg group, ET-26HCl 0.8mg/kg group and Etomidate Injectable Product 0.3mg/kg group
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
3 sitesChina
Study dates
15 Nov 2024to 27 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients undergoing routine gastroscopy/colonoscopy with an expected gastroscopy/colonoscopy procedure time of less than 20 minutes;
  • age ≥ 18 and ≤ 75 years old, regardless of gender;
  • American Society of Anesthesiologists (ASA) grade I-III;
  • Body mass index (BMI) 18-30 kg/m2 (including the cut-off value) and body weight ≤100 kg;
  • Vital signs during screening: respiratory rate ≥10 and ≤24 times/min; Pulse oxygen saturation (SpO2) ≥95% while breathing air; Systolic blood pressure (SBP) ≥90mmHg and ≤160mmHg; Diastolic blood pressure (DBP) ≥60mmHg and ≤100mmHg; Heart rate (ECG) ≥55 and ≤100 beats/min;
  • Serum cortisol concentration was normal or abnormal but not clinically significant according to the investigator's judgment;
  • Able to understand the procedures and methods of this study, willing to sign the informed consent and strictly abide by the trial protocol to complete the study.

Who cannot join

  • patients requiring complex endoscopic techniques (such as cholangiopancreatography, endoscopic ultrasonography, endoscopic mucosal resection, endoscopic submucosal dissection, peroral endoscopic myotomy, etc.) or undergoing tracheal intubation;
  • patients with possible gastroduodenal outflow obstruction with retention of contents or upper gastrointestinal bleeding;
  • patients who were known or suspected to have allergies or contraindications to the components of the investigational drug or the prescribed regimen, or who were suspected to have epilepsy or severe liver and kidney dysfunction;
  • predicted difficulty in intubation or ventilation (e.g., modified Mallampti score Ⅲ-Ⅳ, congenital microglossia, mandibular hypoplasia, etc.);
  • having any of the following respiratory management risks before/at the time of screening: 1) history of asthma, wheezing; 2) sleep apnea syndrome;
  • QTcF≥450 ms (male) or ≥470 ms (female) at screening and confirmed by review; Or clinically significant electrocardiographic abnormalities that were deemed by the investigator to be ineligible for the study;
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  • use of any of the following drugs or treatments before screening:1) enrolled in a clinical trial of any drug within 1 month before screening; 2) use of medications or treatments that affect cortical function within 3 days before screening; 3) Use of medications that may affect QT interval within 2 weeks before screening;
  • Laboratory tests during the screening period meet the following standards:1)AST and ALT ≥ 3×ULN;2)TBIL≥1.5×ULN;3)hemoglobin ≤90 g/L (and no blood transfusion within 14 days); 4)ANC≤1.5×109/L;5)platelet count ≤80×109/L;6)serum creatinine ≥1.5×ULN;
  • pregnant and lactating women; The reluctance of women or men of childbearing potential to use contraception for the entire dosing period; Subjects (including male subjects) who plan to become pregnant within 3 months after the trial;
  • Subjects with any other factors considered by the investigator to be ineligible for participation in the trial

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • Sichuan Academy of Medical Sciences · Sichuan Provincial People's Hospital

    Chengdu, Sichuan

  • Guangyuan First People's Hospital

    Guangyuan, Sichuan, 628017

  • Yibin Second People's Hospital

    Yibin, Sichuan, 644000

Other trials in China

About this study

Official title: A Multicenter, Randomized, Single-blind, Etomidate-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Methoxyethyl Etomidate Hydrochloride for Sedation/Anesthesia During Gastroscopy/Colonoscopy.

A total of 78 subjects undergoing gastroscopy/colonoscopy were randomly assigned to the methoxetomidate hydrochloride group and the etomidate group according to the ratio of 1:1:1 with etomidate as the control group, 26 cases in each group. All subjects were blinded to treatment allocation. Screening assessments for all subjects will be completed within D-14 to D-2 before the first dose. For all subjects who received the investigational drug, they were required to return to the research center on D2-5 to complete the corresponding examination before being discharged from the group. To preliminarily evaluate the efficacy and safety of ET-26 in gastroscopy/colonoscopy.

Being tested
ET-26HCl 0.6mg/kg group, ET-26HCl 0.8mg/kg group, Etomidate Injectable Product 0.3mg/kg group

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ET-26HCl 0.6mg/kg groupDrug

    Also called 0.6mg group

    The initial dose is 0.6 mg/kg, intravenous injection,with an additional 50% starting dose if needed (30second±5second bolus completion). Infusion time was 1minute ± 5second.

  • ET-26HCl 0.8mg/kg groupDrug

    Also called 0.8mg group

    The initial dose is 0.8 mg/kg, intravenous injection,with an additional 50% starting dose if needed (30second±5second bolus completion). Infusion time was 1minute ± 5second.

  • Etomidate Injectable Product 0.3mg/kg groupDrug

    Also called 0.3mg group

    The initial dose is 0.3 mg/kg, intravenous injection,with an additional 50% starting dose if needed (30second±5second bolus completion).Infusion time was 1minute ± 5second.

Study groups in NCT06682546
Study groupRoleWhat they receive
ET-26 0.6 mg groupExperimental0.6mg/kg
Receives: Drug: ET-26HCl 0.6mg/kg group
ET-26 0.8mg groupExperimental0.8mg/kg
Receives: Drug: ET-26HCl 0.8mg/kg group
Etomidate groupActive comparator0.3mg/kg
Receives: Drug: Etomidate Injectable Product 0.3mg/kg group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success rate of gastroscopy/colonoscopy

    Number of appends ≤5; No alternative medications or other sedatives/anesthetics were used from the beginning of the first dose of the trial product until the completion of gastroscopy/colonoscopy.

    Measured: within approximately 15minutes after injection

Secondary outcomes (12)

  1. Sedation/anesthesia success rate

    Percentage of subjects with a MOAA/S score ≤1 after initial dosing of the investigational drug

    Measured: Within approximately 1 minute of the end of the injection

  2. Duration of successful sedation/anesthesia

    The time from the first administration of the experimental drug to the MOAA/S score ≤1

    Measured: within approximately 1minute after injection

  3. Insertion duration

    The time between initial administration of the investigational drug and successful insertion of the lens

    Measured: within approximately 7minutes after the first injection

  4. Success rate of lens insertion

    Percentage of subjects with successful insertion

    Measured: within approximately 7minutes after the last injection

  5. Duration from completion of experimental drug administration to full recovery

    The time between the completion of the last trial drug administration and the subject's full recovery (the first of three consecutive MOAA/S scores of 5)

    Measured: Within approximately 30 minutes of the completion of the last injection

  6. The time from the end of treatment to full consciousness

    The time from gastroscopy/colonoscopy withdrawal until the subject is fully awake (the first of three consecutive MOAA/S scores of 5)

    Measured: Within approximately 30 minutes of the completion of the first injection

  7. Duration from the end of treatment to the end of the room

    The first occurrence time from gastroscopy/colonoscopy withdrawal to 3 consecutive departures with Aldrete score ≥9

    Measured: A maximum of 10 minutes after awakening

  8. The time when BIS reaches 60 or below

    The period from the beginning of first dosing of the investigational product to the first BIS of 60 or less

    Measured: within approximately 5minutes after injection

  9. The length of BIS between 40 and 60

    Duration of BIS values between 40 and 60, including boundary values

    Measured: within 7minutes after injection

  10. Rate of use of remedial drugs

    Percentage of subjects who had used the sedative/anesthetic remedy propofol injection once or more

    Measured: within 60minutes after injection

  11. Test drug additions

    the additional situation and dosage of drugs were summarized

    Measured: within 30minutes after injection

  12. Cognitive function evaluation

    Mini-mental State Examination

    Measured: Maximum 40 minutes after awakening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2024
  2. Study start15 Nov 2024
  3. Primary completion27 Dec 2024
  4. Study completion27 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06682546
Sponsor's protocol ID
ET-26-HCl-202
Status last verified
May 2025
First submitted
7 Nov 2024
Last updated
25 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ET-26HCl 0.6mg/kg group, ET-26HCl 0.8mg/kg group and Etomidate Injectable Product 0.3mg/kg group in people with Gastroscopy and Colonoscopy, run by Ahon Pharmaceutical Co., Ltd. at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of gastroscopy/colonoscopy (time frame: within approximately 15minutes after injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06682546.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.

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