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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
Sponsor:
Information provided by (Responsible Party):
Poong-Lyul Rhee, Samsung Medical Center

Study Description
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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.


Condition or disease Intervention/treatment
Irritable Bowel Syndrome Drug: Amitriptyline

Study Design
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Study Type : Observational
Estimated Enrollment : 118 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

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Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. treatment responses of bloating [ Time Frame: After the intervention period of 4 weeks, the treatment response was determined. ]
  3. treatment responses of overall IBS symptoms scores [ Time Frame: After the intervention period of 4 weeks, the treatment response was determined. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638870


Contacts
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Contact: Yang Won Min, M.D. +82-10-2656-2293 gwon.min@samsung.com

Locations
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Korea, Republic of
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Poong-Lyul Rhee, M.D.,Ph.D. Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
More Information
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Responsible Party: Poong-Lyul Rhee, Prof., Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02638870    
Other Study ID Numbers: 2015-08-109
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Amitriptyline
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants