Colonoscopy-related Pain Predicts the Treatment Response of Amitriptyline in Patients With Irritable Bowel Syndrome
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|ClinicalTrials.gov Identifier: NCT02638870|
Recruitment Status : Unknown
Verified December 2015 by Poong-Lyul Rhee, Samsung Medical Center.
Recruitment status was: Not yet recruiting
First Posted : December 23, 2015
Last Update Posted : December 24, 2015
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.
|Condition or disease||Intervention/treatment|
|Irritable Bowel Syndrome||Drug: Amitriptyline|
|Study Type :||Observational|
|Estimated Enrollment :||118 participants|
|Official Title:||Colonoscopy-related Pain Predicts the Treatment Response of Amitriptyline in Patients With Irritable Bowel Syndrome|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||October 2016|
- Drug: 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.
- 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.
- treatment responses of urgency of defecation [ Time Frame: After the intervention period of 4 weeks, the treatment response was determined. ]The secondary outcomes were the treatment responses of urgency of defecation, bloating, and overall IBS symptoms scores.
- 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. ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638870
|Contact: Yang Won Min, M.D.||+firstname.lastname@example.org|
|Korea, Republic of|
|Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Poong-Lyul Rhee, M.D.,Ph.D.||Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine|