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Clinical Trials/NCT02638870
NCT02638870
Unknown
Not Applicable

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

Samsung Medical Center1 site in 1 country118 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Irritable Bowel Syndrome
Sponsor
Samsung Medical Center
Enrollment
118
Locations
1
Primary Endpoint
treatment response of abdominal pain/discomfort
Last Updated
10 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
October 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Poong-Lyul Rhee

Prof.

Samsung Medical Center

Eligibility Criteria

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.)

Study Sites (1)

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