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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02638870
• Other study ID #: 2015-08-109
• Status: Not yet recruiting
• Phase: N/A
• First received: December 20, 2015
• Last updated: December 23, 2015
• Start date: January 2016
• Est. completion date: October 2016

Study information

• Verified date: December 2015
• Source: Samsung Medical Center
• Contact: Yang Won Min, M.D.
• Phone: +82-10-2656-2293
• Email: gwon.min[@]samsung.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	After the intervention period of 4 weeks, the treatment response was determined.	No
Secondary	treatment responses of urgency of defecation	The secondary outcomes were the treatment responses of urgency of defecation, bloating, and overall IBS symptoms scores.	After the intervention period of 4 weeks, the treatment response was determined.	No
Secondary	treatment responses of bloating		After the intervention period of 4 weeks, the treatment response was determined.	No
Secondary	treatment responses of overall IBS symptoms scores		After the intervention period of 4 weeks, the treatment response was determined.	No