GlycopyrrolatePhase 1/2NCT06041984
Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy
A Phase 1/2 study testing Glycopyrrolate in people with Glycopyrrolate and Colonoscopy, run by Jie Chen at 1 site in China.
Trial summary
The purpose of this study is to determine the antiperistaltic effect and safety of glycopyrrolate and whether the use of glycopyrrolate is beneficial for colonoscopy and colonoscopic polypectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Glycopyrrolate, Colonoscopy
- What is being tested?
- Glycopyrrolate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2023to Jun 2024
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80 years old.
- Outpatients and inpatients with lesions to be resected under colonoscopy.
- Participants voluntarily participated and signed informed consent forms.
Who cannot join
- Pregnancy status and lactating women.
- With glaucoma, myasthenia gravis, hyperthyroidism, chronic renal insufficiency, and inflammatory bowel disease.
- With obstructive gastrointestinal diseases such as pyloric obstruction, paralytic ileus, and achalasia of the cardia.
- With obstructive urinary tract diseases such as prostatic hyperplasia and dysuria.
- With heart disease such as arrhythmia (bradycardia, tachycardia, ventricular fibrillation, atrial fibrillation, etc.), coronary heart disease, congestive heart failure.
- With a history of previous abdominal or intestinal surgery.
- Anticholinergic drugs were administered 48 hours before surgery.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital Of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
About this study
Official title: Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy: a Randomized, Double-blind, Placebo-controlled Study
The purpose of this study is to determine the antiperistaltic effect and safety of glycopyrrolate and whether the use of glycopyrrolate is beneficial for colonoscopy and colonoscopic polypectomy.
Read the detailed description
Colonic spasm is a major adverse event affecting colonoscopy.The current mainstay for the prevention of colonic spasm is the use of antispasmodic.Glycopyrrolate is a long-acting quaternary ammonium anticholinergic drug.The study is designed as a randomized, double-blind, placebo-controlled study of the efficacy and safety of glycopyrrolate in participants receiving colonoscopy and colonoscopic polypectomy. Patients at our center who met the inclusion criteria were randomized into the glycopyrrolate group and the placebo group, and then statistically analyzed whether there was any difference in the incidence of spasticity, spasticity scores, polyp treatment time, and satisfaction with endoscopist operation between the two groups.
- Conditions
- Glycopyrrolate, Colonoscopy
- Being tested
- Glycopyrrolate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycopyrrolateDrug
Intravenous injection of glycopyrrolate 0.2mg
PlaceboOther
Intravenous injection of saline 1ml
| Study group | Role | What they receive |
|---|---|---|
| Glycopyrrolate | Experimental | Participants will receive intravenous glycopyrrolate 0.2 mg while receiving anesthetic. Receives: Drug: Glycopyrrolate |
| Placebo | Placebo comparator | Participants will receive intravenous 1ml saline while receiving anesthetic. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intestinal spasm
The incidence of intestinal spasm in the two groups was calculated after determining whether colonic spasms occurred according to the inhibitory effect score.Rated on a scale of 1 to 3 according to the luminal opening diameter:1 (excellent): no spasm,lumen opening ≥ 2/3 of maximum diameter， 2 (fair): moderate spasm，lumen opening < 2/3 of maximum diameter, but the oral side can be seen and 3 (poor): severe spasm，the oral side lumen is not visible.
Measured: During Colonoscopy
Secondary outcomes (2)
inhibitory effect score
Rated on a scale of 1 to 3 according to the luminal opening diameter:1 (excellent): no spasm,lumen opening ≥ 2/3 of maximum diameter， 2 (fair): moderate spasm，lumen opening < 2/3 of maximum diameter, but the oral side can be seen and 3 (poor): severe spasm，the oral side lumen is not visible.
Measured: During Colonoscopy
Polyp Treatment Time
Time from start of polyp removal to complete polyp removal.
Measured: During Colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start8 Oct 2023
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlycopyrrolateStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jie Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie Chen, The Second Affiliated Hospital of Chongqing Medical University
- Investigators
- Guangyou Duan, doctor, Study director, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041984
- Sponsor's protocol ID
- 2023114
- Status last verified
- Dec 2023
- First submitted
- 12 Sep 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- 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 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiperistaltic Effect and Safety of Glycopyrronium for Colonoscopic Polypectomy: a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06041984
- Acronym / sponsor ID
- 2023114
- Conditions
- Glycopyrrolate, Colonoscopy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Jie ChenUniversity, hospital or other
- Study start
- 8 Oct 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 18 Sep 2023 (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.
The purpose of this study is to determine the antiperistaltic effect and safety of glycopyrrolate and whether the use of glycopyrrolate is beneficial for colonoscopy and colonoscopic polypectomy.
Detailed description
Colonic spasm is a major adverse event affecting colonoscopy.The current mainstay for the prevention of colonic spasm is the use of antispasmodic.Glycopyrrolate is a long-acting quaternary ammonium anticholinergic drug.The study is designed as a randomized, double-blind, placebo-controlled study of the efficacy and safety of glycopyrrolate in participants receiving colonoscopy and colonoscopic polypectomy. Patients at our center who met the inclusion criteria were randomized into the glycopyrrolate group and the placebo group, and then statistically analyzed whether there was any difference in the incidence of spasticity, spasticity scores, polyp treatment time, and satisfaction with endoscopist operation between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glycopyrrolate | Experimental | Drug: GlycopyrrolateParticipants will receive intravenous glycopyrrolate 0.2 mg while receiving anesthetic. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive intravenous 1ml saline while receiving anesthetic. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80 years old.
- Outpatients and inpatients with lesions to be resected under colonoscopy.
- Participants voluntarily participated and signed informed consent forms.
Key exclusion criteria (7 listed)
- Pregnancy status and lactating women.
- With glaucoma, myasthenia gravis, hyperthyroidism, chronic renal insufficiency, and inflammatory bowel disease.
- With obstructive gastrointestinal diseases such as pyloric obstruction, paralytic ileus, and achalasia of the cardia.
- With obstructive urinary tract diseases such as prostatic hyperplasia and dysuria.
- With heart disease such as arrhythmia (bradycardia, tachycardia, ventricular fibrillation, atrial fibrillation, etc.), coronary heart disease, congestive heart failure.
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 |
|---|---|---|
| GlycopyrrolateIntravenous injection of glycopyrrolate 0.2mg | Drug | Glycopyrrolate |
| PlaceboIntravenous injection of saline 1ml | Other | Placebo |
Primary outcome
Incidence of intestinal spasm
Time frame: During Colonoscopy
The incidence of intestinal spasm in the two groups was calculated after determining whether colonic spasms occurred according to the inhibitory effect score.Rated on a scale of 1 to 3 according to the luminal opening diameter:1 (excellent): no spasm,lumen opening ≥ 2/3 of maximum diameter， 2 (fair): moderate spasm，lumen opening < 2/3 of maximum diameter, but the oral side can be seen and 3 (poor): severe spasm，the oral side lumen is not visible.
2 secondary outcomes
inhibitory effect score
Time frame: During Colonoscopy
Polyp Treatment Time
Time frame: During Colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- 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. This study is not recruiting at the moment.
Guangyou Duan, doctor study director
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Glycopyrrolate in people with Glycopyrrolate and Colonoscopy, run by Jie Chen at 1 site 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
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?
Incidence of intestinal spasm (time frame: During Colonoscopy). 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 8 Dec 2023.