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Colonoscopy-related Pain Predicts the Treatment Response of Amitriptyline in Patients With Irritable Bowel Syndrome

NCT ID: NCT02638870

Last Updated: 2015-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Amitriptyline

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with IBS according to the Rome III criteria

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Poong-Lyul Rhee

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Poong-Lyul Rhee, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Locations

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Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Yang Won Min, M.D.

Role: CONTACT

Phone: +82-10-2656-2293

Email: [email protected]

Other Identifiers

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2015-08-109

Identifier Type: -

Identifier Source: org_study_id