Painless Gastrointestinal EndoscopyNCT07271303
A Clinical Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Capsules for Preoperative Preparation in Painless Gastrointestinal Endoscopy Procedures
A study testing Hyoscine Butylbromide in people with Painless Gastrointestinal Endoscopy, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
Gastrointestinal endoscopy procedures, including upper gastrointestinal endoscopy and colorectal endoscopy, represent a fundamental and important method for examining and managing digestive tract diseases, with both diagnostic and therapeutic applications. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Painless Gastrointestinal Endoscopy
- What is being tested?
- Hyoscine Butylbromide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years and ≤75 years, regardless of sex;
- Patients scheduled to undergo painless gastrointestinal endoscopy examination or endoscopic surgery, which must include upper gastrointestinal endoscopy;
- Voluntary participation based on the free will of the subject or their legal guardian, with signed informed consent form.
Who cannot join
- Patients with a history of upper gastrointestinal surgery or colorectal surgery;
- American Society of Anesthesiologists (ASA) classification ≥ Grade III;
- Patients with severe cardiac conditions, including severe arrhythmia, structural heart disease, or other serious cardiac disorders;
- Significant hepatic or renal dysfunction affecting drug metabolism, defined as ALT > 2.5 × ULN, AST > 2.5 × ULN, or Scr > 1.5 × ULN;
- Organic pyloric stenosis, paralytic ileus, or other severe organic gastrointestinal diseases that are unsuitable for painless gastrointestinal endoscopy;
- Patients with suspected gastrointestinal ulcer bleeding or perforation;
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- Patients with glaucoma or prostatic hypertrophy;
- Pregnant or lactating women;
- Known hypersensitivity to any component of the study drug;
- Use of medications affecting gastrointestinal motility within 7 days prior to study enrollment;
- Other conditions unsuitable for painless endoscopy procedures;
- Participation in another drug or medical device clinical trial within 30 days prior to study enrollment;
- Patients deemed unsuitable for participation in this clinical study by the investigator.
About this study
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Capsules for Preoperative Preparation in Painless Gastrointestinal Endoscopy Procedures
Gastrointestinal endoscopy procedures, including upper gastrointestinal endoscopy and colorectal endoscopy, represent a fundamental and important method for examining and managing digestive tract diseases, with both diagnostic and therapeutic applications. They are also utilized as effective tools for surveillance of gastrointestinal tumors. During upper gastrointestinal endoscopy procedures, gastric peristalsis may restrict the operative field of view and access, significantly affecting procedural precision. Excessive peristalsis not only affects the observation of simple lesions but also impacts other procedural maneuvers Therefore, during upper gastrointestinal endoscopy procedures, antispasmodic agents are commonly used to suppress gastrointestinal motility, ultimately facilitating endoscopic visualization. However, most antispasmodic agents, such as hyoscine butylbromide (Buscopan), cimetropium bromide (Algiron), and atropine, must be administered by injection. Intravenous or intramuscular administration causes patient pain and anxiety, and increases medical costs. Some researchers have taken an alternative approach by spraying L-menthol onto the gastric mucosa during gastroscopy to reduce gastric peristalsis. Although study results and adverse reaction profiles have demonstrated its superiority, the application process still presents operational inconveniences. Furthermore, these drugs should be used with caution as they may cause potential adverse reactions, including dry mouth, urinary retention, temporary impairment of visual accommodation, palpitations, anaphylactic shock, and hyperglycemia.
Read the detailed description
Here is the English translation for your study procedures:
- Screening Period (Day -7 to Day -1) The following procedures or assessments are required during the screening period. Electrocardiogram results obtained within 7 days prior to randomization are acceptable. Blood biochemistry, complete blood count, and blood (urine) pregnancy test results obtained within 7 days prior to randomization are acceptable, including results completed before signing informed consent. Signing of informed consent form; Demographics and medical history collection; medical history is limited to current comorbidities and does not include conditions that have been cured; Vital signs: temperature, pulse, blood pressure; Physical examination: general condition, skin and mucosa, head and neck, chest, abdomen; 12-lead electrocardiogram; Complete blood count including at least: red blood cell count, white blood cell count, hemoglobin, platelet count; Blood biochemistry including at least: total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, urea/blood urea nitrogen (BUN); Blood (urine) pregnancy test; Verification of inclusion/exclusion criteria.
- Randomization and Blinding This study employs a random number table method, using SAS version 9.4 or above or other software for randomization. A randomization code table for no fewer than 74 subjects will be generated with a 1:1 ratio between the treatment group and control group. The study is double-blind; hyoscine butylbromide capsules and placebo are identical in appearance, packaging, and administration method, so that neither investigators nor subjects can determine group assignment based on the medication itself. Medications will be dispensed by an independent third party (e.g., pharmacy) to ensure blinding integrity. Each subject will receive 2 capsules of hyoscine butylbromide or placebo, with a total of 74 bags (or bottles, 2 capsules per bag or bottle) for 74 subjects. Medication numbers will correspond one-to-one with subject randomization numbers. Subjects who pass screening will be randomly assigned to either the hyoscine butylbromide capsules + endoscopy group (treatment group) or the placebo + endoscopy group (placebo group).
- Study Medication and Concomitant Treatment The hyoscine butylbromide capsules and placebo used in this study are provided by Guangdong Huanan Pharmaceutical Group Co., Ltd. The dosing regimen is as follows: 30 ± 5 minutes before endoscopy, subjects in the treatment group will take 2 capsules (20 mg) of hyoscine butylbromide, while subjects in the placebo group will take 2 capsules of matching placebo identical in appearance to hyoscine butylbromide capsules. Concomitant treatment: During the study period (from screening until 24 hours after endoscopy completion), the use of medications in the same class as hyoscine butylbromide or medications with equivalent antispasmodic effects is prohibited. Other medications are permitted, including preoperative preparation medications and anesthetic agents for painless endoscopy, as well as medications for the treatment of adverse events or underlying diseases. The timing of use shall be determined by the investigator.
- Endoscopy Procedures Endoscopy procedures should be performed using the same equipment whenever possible and preferably by the same endoscopist. Preoperative preparation for painless endoscopy and procedural protocols shall follow institutional regulations, clinical practice, or relevant clinical practice guidelines.
- Safety Follow-up (Within 24 Hours After Endoscopy Completion) Within 24 hours after endoscopy completion, subjects shall be followed up (telephone follow-up is acceptable) for safety assessment. Vital signs examination shall be completed again within 1 hour after endoscopy completion. Additional examinations or assessments may be performed if other adverse events or abnormal signs are suspected.
During endoscopy and within 24 hours after completion, subjects shall be followed up (telephone follow-up is acceptable) for Visual Analog Scale (VAS) assessment at the time of maximum pain.
- Conditions
- Painless Gastrointestinal Endoscopy
- Being tested
- Hyoscine Butylbromide
- Keywords
- Painless gastrointestinal endoscopy, Hyoscine Butylbromide, Preoperative Preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyoscine ButylbromideDrug
Participants receive hyoscine butylbromide capsules orally before painless gastrointestinal endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Hyoscine Butylbromide Group | Experimental | Participants receive hyoscine butylbromide capsules orally before painless gastrointestinal endoscopy Receives: Drug: Hyoscine Butylbromide |
| Placebo group | No intervention | Participants receive matching placebo capsules orally before painless gastrointestinal endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of gastric peristaltic movements per minute at intraoperative recording points
Evaluation method and criteria for gastric peristalsis frequency: A third-party investigator will count the number of peristaltic movements from the endoscopic video recordings. After documenting the results, a statistician will calculate the mean value per minute.
Measured: During endoscopy procedure
Secondary outcomes (2)
Number of intestinal peristaltic movements per minute at intraoperative recording points
Evaluation method and criteria for intestinal peristalsis frequency: A third-party investigator will count the number of peristaltic movements from the endoscopic video recordings. After documenting the results, a statistician will calculate the mean value per minute.
Measured: During endoscopy procedure
Procedural observation time
Defined as the time interval from endoscope insertion to complete withdrawal (recorded separately for upper gastrointestinal endoscopy and colorectal endoscopy).
Measured: During endoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Feb 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painless Gastrointestinal EndoscopyStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaobo Li, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07271303
- Sponsor's protocol ID
- LY2025-335-A
- Status last verified
- Jan 2026
- First submitted
- 27 Nov 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Capsules for Preoperative Preparation in Painless Gastrointestinal Endoscopy Procedures
- ClinicalTrials.gov ID
- NCT07271303
- Acronym / sponsor ID
- LY2025-335-A
- Conditions
- Painless Gastrointestinal Endoscopy
- Keywords
- Painless gastrointestinal endoscopy, Hyoscine Butylbromide, Preoperative Preparation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastrointestinal endoscopy procedures, including upper gastrointestinal endoscopy and colorectal endoscopy, represent a fundamental and important method for examining and managing digestive tract diseases, with both diagnostic and therapeutic applications. They are also utilized as effective tools for surveillance of gastrointestinal tumors. During upper gastrointestinal endoscopy procedures, gastric peristalsis may restrict the operative field of view and access, significantly affecting procedural precision. Excessive peristalsis not only affects the observation of simple lesions but also impacts other procedural maneuvers Therefore, during upper gastrointestinal endoscopy procedures, antispasmodic agents are commonly used to suppress gastrointestinal motility, ultimately facilitating endoscopic visualization. However, most antispasmodic agents, such as hyoscine butylbromide (Buscopan), cimetropium bromide (Algiron), and atropine, must be administered by injection. Intravenous or intramuscular administration causes patient pain and anxiety, and increases medical costs. Some researchers have taken an alternative approach by spraying L-menthol onto the gastric mucosa during gastroscopy to reduce gastric peristalsis. Although study results and adverse reaction profiles have demonstrated its superiority, the application process still presents operational inconveniences. Furthermore, these drugs should be used with caution as they may cause potential adverse reactions, including dry mouth, urinary retention, temporary impairment of visual accommodation, palpitations, anaphylactic shock, and hyperglycemia.
Detailed description
Here is the English translation for your study procedures:
- Screening Period (Day -7 to Day -1) The following procedures or assessments are required during the screening period. Electrocardiogram results obtained within 7 days prior to randomization are acceptable. Blood biochemistry, complete blood count, and blood (urine) pregnancy test results obtained within 7 days prior to randomization are acceptable, including results completed before signing informed consent. Signing of informed consent form; Demographics and medical history collection; medical history is limited to current comorbidities and does not include conditions that have been cured; Vital signs: temperature, pulse, blood pressure; Physical examination: general condition, skin and mucosa, head and neck, chest, abdomen; 12-lead electrocardiogram; Complete blood count including at least: red blood cell count, white blood cell count, hemoglobin, platelet count; Blood biochemistry including at least: total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, urea/blood urea nitrogen (BUN); Blood (urine) pregnancy test; Verification of inclusion/exclusion criteria.
- Randomization and Blinding This study employs a random number table method, using SAS version 9.4 or above or other software for randomization. A randomization code table for no fewer than 74 subjects will be generated with a 1:1 ratio between the treatment group and control group. The study is double-blind; hyoscine butylbromide capsules and placebo are identical in appearance, packaging, and administration method, so that neither investigators nor subjects can determine group assignment based on the medication itself. Medications will be dispensed by an independent third party (e.g., pharmacy) to ensure blinding integrity. Each subject will receive 2 capsules of hyoscine butylbromide or placebo, with a total of 74 bags (or bottles, 2 capsules per bag or bottle) for 74 subjects. Medication numbers will correspond one-to-one with subject randomization numbers. Subjects who pass screening will be randomly assigned to either the hyoscine butylbromide capsules + endoscopy group (treatment group) or the placebo + endoscopy group (placebo group).
- Study Medication and Concomitant Treatment The hyoscine butylbromide capsules and placebo used in this study are provided by Guangdong Huanan Pharmaceutical Group Co., Ltd. The dosing regimen is as follows: 30 ± 5 minutes before endoscopy, subjects in the treatment group will take 2 capsules (20 mg) of hyoscine butylbromide, while subjects in the placebo group will take 2 capsules of matching placebo identical in appearance to hyoscine butylbromide capsules. Concomitant treatment: During the study period (from screening until 24 hours after endoscopy completion), the use of medications in the same class as hyoscine butylbromide or medications with equivalent antispasmodic effects is prohibited. Other medications are permitted, including preoperative preparation medications and anesthetic agents for painless endoscopy, as well as medications for the treatment of adverse events or underlying diseases. The timing of use shall be determined by the investigator.
- Endoscopy Procedures Endoscopy procedures should be performed using the same equipment whenever possible and preferably by the same endoscopist. Preoperative preparation for painless endoscopy and procedural protocols shall follow institutional regulations, clinical practice, or relevant clinical practice guidelines.
- Safety Follow-up (Within 24 Hours After Endoscopy Completion) Within 24 hours after endoscopy completion, subjects shall be followed up (telephone follow-up is acceptable) for safety assessment. Vital signs examination shall be completed again within 1 hour after endoscopy completion. Additional examinations or assessments may be performed if other adverse events or abnormal signs are suspected.
During endoscopy and within 24 hours after completion, subjects shall be followed up (telephone follow-up is acceptable) for Visual Analog Scale (VAS) assessment at the time of maximum pain.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyoscine Butylbromide Group | Experimental | Drug: Hyoscine ButylbromideParticipants receive hyoscine butylbromide capsules orally before painless gastrointestinal endoscopy |
| Placebo group | No intervention | –Participants receive matching placebo capsules orally before painless gastrointestinal endoscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years and ≤75 years, regardless of sex;
- Patients scheduled to undergo painless gastrointestinal endoscopy examination or endoscopic surgery, which must include upper gastrointestinal endoscopy;
- Voluntary participation based on the free will of the subject or their legal guardian, with signed informed consent form.
Key exclusion criteria (13 listed)
- Patients with a history of upper gastrointestinal surgery or colorectal surgery;
- American Society of Anesthesiologists (ASA) classification ≥ Grade III;
- Patients with severe cardiac conditions, including severe arrhythmia, structural heart disease, or other serious cardiac disorders;
- Significant hepatic or renal dysfunction affecting drug metabolism, defined as ALT > 2.5 × ULN, AST > 2.5 × ULN, or Scr > 1.5 × ULN;
- Organic pyloric stenosis, paralytic ileus, or other severe organic gastrointestinal diseases that are unsuitable for painless gastrointestinal endoscopy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyoscine ButylbromideParticipants receive hyoscine butylbromide capsules orally before painless gastrointestinal endoscopy | Drug | Hyoscine Butylbromide Group |
Primary outcome
Number of gastric peristaltic movements per minute at intraoperative recording points
Time frame: During endoscopy procedure
Evaluation method and criteria for gastric peristalsis frequency: A third-party investigator will count the number of peristaltic movements from the endoscopic video recordings. After documenting the results, a statistician will calculate the mean value per minute.
2 secondary outcomes
Number of intestinal peristaltic movements per minute at intraoperative recording points
Time frame: During endoscopy procedure
Procedural observation time
Time frame: During endoscopy procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hyoscine Butylbromide in people with Painless Gastrointestinal Endoscopy, run by Shanghai Jiao Tong University School of Medicine.
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 3 inclusion and 13 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Number of gastric peristaltic movements per minute at intraoperative recording points (time frame: During endoscopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2026.