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

NCT02638870 | Unknown

• 1 other identifier: 2015-08-109
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (3)

• 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.

Interventions

Amitriptyline DRUG

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with IBS according to the Rome III criteria were recruited in the outpatient clinic at Samsung Medical Center. Inclusion criteria were age 18-75 years and no evidence of inflammatory bowel disease or malignancy on colonoscopy.

You may qualify if:

• Patients with IBS according to the Rome III criteria

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

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

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Amitriptyline

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Poong-Lyul Rhee, M.D.,Ph.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Won Min, M.D.

CONTACT

+82-10-2656-2293; gwon.min@samsung.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 20, 2015
• First Posted: December 23, 2015
• Study Start: January 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

KR (1)