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Clinical Trials/NCT02638870
NCT02638870UnknownNot Applicable

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

Samsung Medical Center1 site in 1 country118 target enrollmentStarted: January 2016Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Enrollment
118
Locations
1
Primary Endpoint
treatment response of abdominal pain/discomfort

Study Overview

Brief 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. 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

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • treatment responses of urgency of defecation(After the intervention period of 4 weeks, the treatment response was determined.)
  • treatment responses of bloating(After the intervention period of 4 weeks, the treatment response was determined.)
  • treatment responses of overall IBS symptoms scores(After the intervention period of 4 weeks, the treatment response was determined.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Poong-Lyul Rhee

Prof.

Samsung Medical Center

Study Sites (1)

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