Irritable Bowel SyndromeNCT02638870
Colonoscopy-related Pain Predicts the Treatment Response of Amitriptyline in Patients With Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Irritable bowel syndrome (IBS) is a functional bowel disorder with recurrent abdominal pain and disordered defecation and is one of the most common gastrointestinal problems. In practice, IBS was frequently diagnosed as an exclusion diagnosis for patients with recurrent abdominal pain without an organic cause. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Amitriptyline
- How many people
- 118 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Oct 2016
- Phase
- Observational
- 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
Study population: Patients with IBS according to the Rome III criteria were recruited in the outpatient clinic at Samsung Medical Center. Inclusion criteria were age 18-75 years and no evidence of inflammatory bowel disease or malignancy on colonoscopy.
Who may be able to join
- Patients with IBS according to the Rome III criteria
Who cannot join
- Inflammatory bowel disease or malignancy on colonoscopy.
- Previous abdominal surgery other than appendectomy or cesarean delivery,
- Major psychiatric disorders or Beck Depression Inventory-II score of ≥19
- Significant cardiopulmonary diseases or any malignancies
- Taking pain modulators including selective serotonin reuptake inhibitors (SSRI) or tricyclic antidepressants
- Polypectomy during colonoscopy.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710
About this study
Irritable bowel syndrome (IBS) is a functional bowel disorder with recurrent abdominal pain and disordered defecation and is one of the most common gastrointestinal problems. In practice, IBS was frequently diagnosed as an exclusion diagnosis for patients with recurrent abdominal pain without an organic cause. Visceral hypersensitivity is the major contributing factor of abdominal pain in IBS. Accordingly, tricyclic antidepressants (TCAs) are widely used for IBS, especially if abdominal pain is a prominent symptom. Indeed, meta-analysis also exhibits the clinically significant efficacy of low dose TCAs in IBS. Nevertheless, over 40% of IBS patients receiving TCAs had no improvement in symptoms after treatment. Theoretically, if TCAs are used for IBS patients with hypersensitivity, its efficacy could be increased.
Although rectal distension test might be used to identify hypersensitive patients with IBS, it has been used only for clinical research because it is painful for the patient. On the contrary, colonoscopy is frequently performed in IBS patients to rule out organic disease and for the purpose of colorectal cancer screening. In a study by Kim and colleagues, IBS patients reported higher pain score after colonoscopy than non-IBS patients. This has prompted the hypothesis that pain scoring during/after colonoscopy could also segregate IBS patients with visceral hypersensitivity showing better treatment response of TCA than those without.
The aims of the present study were to evaluate the colonoscopy-related pain perception and the treatment response of amitriptyline in IBS patients and to investigate the predictive values of the colonoscopy-related pain scale in identifying IBS patients with a response to amitriptyline treatment.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Amitriptyline
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmitriptylineDrug
This was a prospective, observational study conducted at Samsung Medical Center, Seoul, Korea. Enrolled IBS patients underwent colonoscopy and colonoscopy-related pain score was evaluated. After colonoscopy, all patients received 5 mg amitriptyline once daily at bedtime for the first week and 10 mg for the subsequent 3 weeks. After the intervention period of 4 weeks, the treatment response was determined.
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment response of abdominal pain/discomfort
The primary outcome was the treatment response of abdominal pain/discomfort. The investigators defined a response when a patient experienced a fall of 30% in abdominal symptom compared to baseline.
Measured: After the intervention period of 4 weeks, the treatment response was determined.
Secondary outcomes (3)
treatment responses of urgency of defecation
The secondary outcomes were the treatment responses of urgency of defecation, bloating, and overall IBS symptoms scores.
Measured: After the intervention period of 4 weeks, the treatment response was determined.
treatment responses of bloating
Measured: After the intervention period of 4 weeks, the treatment response was determined.
treatment responses of overall IBS symptoms scores
Measured: After the intervention period of 4 weeks, the treatment response was determined.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionAug 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Poong-Lyul Rhee, Samsung Medical Center
- Investigators
- Poong-Lyul Rhee, M.D.,Ph.D., Principal investigator, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638870
- Sponsor's protocol ID
- 2015-08-109
- Status last verified
- Dec 2015
- First submitted
- 20 Dec 2015
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colonoscopy-related Pain Predicts the Treatment Response of Amitriptyline in Patients With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02638870
- Acronym / sponsor ID
- 2015-08-109
- Conditions
- Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 23 Dec 2015 (estimated)
- 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.
Irritable bowel syndrome (IBS) is a functional bowel disorder with recurrent abdominal pain and disordered defecation and is one of the most common gastrointestinal problems. In practice, IBS was frequently diagnosed as an exclusion diagnosis for patients with recurrent abdominal pain without an organic cause. Visceral hypersensitivity is the major contributing factor of abdominal pain in IBS. Accordingly, tricyclic antidepressants (TCAs) are widely used for IBS, especially if abdominal pain is a prominent symptom. Indeed, meta-analysis also exhibits the clinically significant efficacy of low dose TCAs in IBS. Nevertheless, over 40% of IBS patients receiving TCAs had no improvement in symptoms after treatment. Theoretically, if TCAs are used for IBS patients with hypersensitivity, its efficacy could be increased.
Although rectal distension test might be used to identify hypersensitive patients with IBS, it has been used only for clinical research because it is painful for the patient. On the contrary, colonoscopy is frequently performed in IBS patients to rule out organic disease and for the purpose of colorectal cancer screening. In a study by Kim and colleagues, IBS patients reported higher pain score after colonoscopy than non-IBS patients. This has prompted the hypothesis that pain scoring during/after colonoscopy could also segregate IBS patients with visceral hypersensitivity showing better treatment response of TCA than those without.
The aims of the present study were to evaluate the colonoscopy-related pain perception and the treatment response of amitriptyline in IBS patients and to investigate the predictive values of the colonoscopy-related pain scale in identifying IBS patients with a response to amitriptyline treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with IBS according to the Rome III criteria were recruited in the outpatient clinic at Samsung Medical Center. Inclusion criteria were age 18-75 years and no evidence of inflammatory bowel disease or malignancy on colonoscopy.
Key inclusion criteria (1 listed)
- Patients with IBS according to the Rome III criteria
Key exclusion criteria (6 listed)
- Inflammatory bowel disease or malignancy on colonoscopy.
- Previous abdominal surgery other than appendectomy or cesarean delivery,
- Major psychiatric disorders or Beck Depression Inventory-II score of ≥19
- Significant cardiopulmonary diseases or any malignancies
- Taking pain modulators including selective serotonin reuptake inhibitors (SSRI) or tricyclic antidepressants
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 |
|---|---|---|
| AmitriptylineThis was a prospective, observational study conducted at Samsung Medical Center, Seoul, Korea. Enrolled IBS patients underwent colonoscopy and colonoscopy-related pain score was evaluated. After colonoscopy, all patients received 5 mg amitriptyline once daily at bedtime for the first week and 10 mg for the subsequent 3 weeks. After the intervention period of 4 weeks, the treatment response was determined. | Drug | – |
Primary outcome
treatment response of abdominal pain/discomfort
Time frame: After the intervention period of 4 weeks, the treatment response was determined.
The primary outcome was the treatment response of abdominal pain/discomfort. The investigators defined a response when a patient experienced a fall of 30% in abdominal symptom compared to baseline.
3 secondary outcomes
treatment responses of urgency of defecation
Time frame: After the intervention period of 4 weeks, the treatment response was determined.
treatment responses of bloating
Time frame: After the intervention period of 4 weeks, the treatment response was determined.
treatment responses of overall IBS symptoms scores
Time frame: After the intervention period of 4 weeks, the treatment response was determined.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
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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.
Poong-Lyul Rhee, M.D.,Ph.D. principal investigator
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Samsung Medical Center at 1 site in South Korea.
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 1 inclusion and 6 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 24 Dec 2015. 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 South Korea. 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.
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 Yang Won Min, M.D. (+82-10-2656-2293, gwon.min@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment response of abdominal pain/discomfort (time frame: After the intervention period of 4 weeks, the treatment response was determined.). 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 24 Dec 2015.