Upper Gastrointestinal EndoscopyPhase 3Non-BuscopanNCT04593836
Antiperistaltic Effect and Safety of L-menthol in the Elderly With Contraindication to Buscopan
A Phase 3 study testing L-menthol in people with Upper Gastrointestinal Endoscopy, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
antiperistaltic effect and safety of L-menthol versus placebo for upper GI endoscopy in elderly patient with contraindication to Buscopan: randomized study Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Upper Gastrointestinal Endoscopy
- What is being tested?
- L-menthol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2012to Dec 2020
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- >65 years old
- routine endoscopic examination
- Contraindication to Buscopan(such as arrhythmia, glaucoma, benign prostatic hyperplasia, ischemic heart disease...)
Who cannot join
- Status post gastric or duodenal surgery
- The patient with critical illness are not suitable for the endoscopic examination
- Upper gastrointestinal bleeding
- Gastric tumor
- Gastric or duodenal ulcers are larger than 2 cm
- Severe pyloric obstruction or deformity
- Cancer patients received chemotherapy or radiation therapy
- Had peppermint allergy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Ming-Chih Hou, MD, 886-2-28712121 ext. 1320, mchou@vghtpe.gov.tw
Han-Chieh Lin, MD, 886-2-28712121 ext. 7506, hclin@vghtpe.gov.tw
About this study
Official title: Antiperistaltic Effect and Safety of L-menthol and Placebo for Upper GI Endoscopy in the Elderly With Contraindication to Buscopan: a Prospective, Randomized, Double-blind Study
antiperistaltic effect and safety of L-menthol versus placebo for upper GI endoscopy in elderly patient with contraindication to Buscopan: randomized study
Read the detailed description
Endoscopy is a important tool for diagnosis and treatment of gastrointestinal diseases. Effective inhibition of gastrointestinal motility during examination is important to achieve good results and quality.
Traditionally, hyoscine-N-butylbromide (Buscopan) is the most commonly used drugs that inhibit intestinal peristalsis. But the side effects of drugs were mentioned in many studies, such as arrhythmia, increased glaucoma, dysuria in patients who have benign prostatic hypertrophy and allergic reactions, and may even cause anaphylactic shock. Peppermint oil is the extract of the natural plant (Mentha X piperita L) which was growth in North America and Europe. L-menthol is main component of peppermint oil. In animal experiments, peppermint oil had effect of calcium channel blockers and cause gastrointestinal smooth muscle relaxing effect. Clinically, peppermint oil preparations were used to relieve stress headache, non-ulcer dyspepsia and irritable bowel syndrome. The oral or intestinal local spraying of peppermint oil or L-menthol showed inhibition of intestinal peristalsis in many studies, and improved colonoscopy, barium enema, retrograde cholangiography , and upper gastrointestinal endoscopy examination.
With the aging of the population of Taiwan and the universality of endoscopy for elderly patients, the safety of endoscopy in elderly patients has more and more attention. According to ASGA guidelines, age is not a contraindication for endoscopy. But 50% of elderly patients have contraindications for hyoscine-N-butylbromide use. Therefore, effort to find alternative medicine to improve quality of endoscopy in elderly patients is necessary. Therefore, the investigators design a research for comparing effect and safety of L-menthol and placebo in elderly patients who have contraindication of hyoscine-N-butylbromide.
- Conditions
- Upper Gastrointestinal Endoscopy
- Being tested
- L-menthol, Placebo
- Keywords
- Upper gastrointestinal endoscopy, Peppermint oil, L-menthol, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-mentholDrug
Also called Peppermint oil
20ml 0.8% L-menthol spray on the pyloric ring and observe the gastric peristalsis
PlaceboDrug
Also called Olive oil
20ml 0.8% placebo spray on the pyloric ring and observe the gastric peristalsis
| Study group | Role | What they receive |
|---|---|---|
| L-menthol | Experimental | 20ml 0.8% L-menthol spray on the pyloric ring and observe the gastric peristalsis Receives: Drug: L-menthol |
| Placebo | Placebo comparator | 20ml 0.8% placebo spray on the pyloric ring and observe the gastric peristalsis Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peristaltic grade
Grade 1: no peristalsis; grade 2: mild peristalsis; grade 3: moderate peristalsis; grade 4: vigorous peristalsis; grade 5: markedly vigorous peristalsis.
Measured: 10 mins
Secondary outcomes (5)
Pylorus contraction ratio
Contraction ratio (%)= [(maximal pyloric ring diameter - minimal pyloric ring diameter)/minimal pyloric ring diameter] x 100
Measured: 3 mins
Pylorus opening ratio: maximum and minimum
Opening ratio (%) = [(pyloric ring diameter after administration of the antispasmodic agent - pyloric ring diameter before administration of the antispasmodic agent) / pyloric ring diameter before administration of the antispasmodic agent] x 100
Measured: 3 mins
Adverse effect of patients
record all adverse effect after study, include abdominal pain, heart burn, headache, allergy, etc.
Measured: 48 hours
VAS score of patient about procedure
VAS score 1-10 about the painful sensation of patient during procedure
Measured: 10 mins
Satisfaction of endoscopist
Four score was evaluated: very easy, easy, slightly difficult and difficult about the procedure due to gastric spasm
Measured: 10 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study startMar 2012
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal EndoscopyStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ming-Chih Hou, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593836
- Sponsor's protocol ID
- V101A-002
- Acronym
- Non-Buscopan
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2013
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang TC, Chen PH, Hou MC, Peng LN, Lin MH, Chen LK, Huang YH. Antiperistaltic effect and safety of L-menthol for esophagogastroduodenoscopy in the elderly with contraindication to hyoscine-N-butylbromide. Sci Rep. 2022 Jun 21;12(1):10418. doi: 10.1038/s41598-022-14693-x.
PubMed 35729250
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiperistaltic Effect and Safety of L-menthol and Placebo for Upper GI Endoscopy in the Elderly With Contraindication to Buscopan: a Prospective, Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT04593836
- Acronym / sponsor ID
- Non-Buscopan / V101A-002
- Conditions
- Upper Gastrointestinal Endoscopy
- Keywords
- Upper gastrointestinal endoscopy, Peppermint oil, L-menthol, Elderly
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Mar 2012 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 Oct 2020 (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.
antiperistaltic effect and safety of L-menthol versus placebo for upper GI endoscopy in elderly patient with contraindication to Buscopan: randomized study
Detailed description
Endoscopy is a important tool for diagnosis and treatment of gastrointestinal diseases. Effective inhibition of gastrointestinal motility during examination is important to achieve good results and quality.
Traditionally, hyoscine-N-butylbromide (Buscopan) is the most commonly used drugs that inhibit intestinal peristalsis. But the side effects of drugs were mentioned in many studies, such as arrhythmia, increased glaucoma, dysuria in patients who have benign prostatic hypertrophy and allergic reactions, and may even cause anaphylactic shock. Peppermint oil is the extract of the natural plant (Mentha X piperita L) which was growth in North America and Europe. L-menthol is main component of peppermint oil. In animal experiments, peppermint oil had effect of calcium channel blockers and cause gastrointestinal smooth muscle relaxing effect. Clinically, peppermint oil preparations were used to relieve stress headache, non-ulcer dyspepsia and irritable bowel syndrome. The oral or intestinal local spraying of peppermint oil or L-menthol showed inhibition of intestinal peristalsis in many studies, and improved colonoscopy, barium enema, retrograde cholangiography , and upper gastrointestinal endoscopy examination.
With the aging of the population of Taiwan and the universality of endoscopy for elderly patients, the safety of endoscopy in elderly patients has more and more attention. According to ASGA guidelines, age is not a contraindication for endoscopy. But 50% of elderly patients have contraindications for hyoscine-N-butylbromide use. Therefore, effort to find alternative medicine to improve quality of endoscopy in elderly patients is necessary. Therefore, the investigators design a research for comparing effect and safety of L-menthol and placebo in elderly patients who have contraindication of hyoscine-N-butylbromide.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L-menthol | Experimental | Drug: L-menthol20ml 0.8% L-menthol spray on the pyloric ring and observe the gastric peristalsis |
| Placebo | Placebo comparator | Drug: Placebo20ml 0.8% placebo spray on the pyloric ring and observe the gastric peristalsis |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- >65 years old
- routine endoscopic examination
- Contraindication to Buscopan(such as arrhythmia, glaucoma, benign prostatic hyperplasia, ischemic heart disease...)
Key exclusion criteria (8 listed)
- Status post gastric or duodenal surgery
- The patient with critical illness are not suitable for the endoscopic examination
- Upper gastrointestinal bleeding
- Gastric tumor
- Gastric or duodenal ulcers are larger than 2 cm
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 |
|---|---|---|
| L-mentholAlso: Peppermint oil20ml 0.8% L-menthol spray on the pyloric ring and observe the gastric peristalsis | Drug | L-menthol |
| PlaceboAlso: Olive oil20ml 0.8% placebo spray on the pyloric ring and observe the gastric peristalsis | Drug | Placebo |
Primary outcome
Peristaltic grade
Time frame: 10 mins
Grade 1: no peristalsis; grade 2: mild peristalsis; grade 3: moderate peristalsis; grade 4: vigorous peristalsis; grade 5: markedly vigorous peristalsis.
5 secondary outcomes
Pylorus contraction ratio
Time frame: 3 mins
Pylorus opening ratio: maximum and minimum
Time frame: 3 mins
Adverse effect of patients
Time frame: 48 hours
VAS score of patient about procedure
Time frame: 10 mins
Satisfaction of endoscopist
Time frame: 10 mins
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Derived from this study: PubMed 35729250Yang TC, Chen PH, Hou MC, Peng LN, Lin MH, Chen LK, Huang YH. Antiperistaltic effect and safety of L-menthol for esophagogastroduodenoscopy in the elderly with contraindication to hyoscine-N-butylbromide. Sci Rep. 2022 Jun 21;12(1):10418. doi: 10.1038/s41598-022-14693-x.
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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.
Ming-Chih Hou, MD principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-menthol in people with Upper Gastrointestinal Endoscopy, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 8 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 20 Oct 2020. 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 Taiwan. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Ming-Chih Hou, MD (886-2-28712121 ext. 1320, mchou@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peristaltic grade (time frame: 10 mins). 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 NCT04593836, which also lists 1 linked publication.
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 Oct 2020.