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Trial record 21 of 135 for:    AMITRIPTYLINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date December 20, 2015
First Posted Date December 23, 2015
Last Update Posted Date December 24, 2015
Study Start Date January 2016
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 23, 2015)
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.
Original Primary Outcome Measures
 (submitted: December 20, 2015)
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. We defined a response when a patient experienced a fall of 30% in abdominal symptom compared to baseline.
Change History Complete list of historical versions of study NCT02638870 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 20, 2015)
  • 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. ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Colonoscopy-related Pain Predicts the Treatment Response of Amitriptyline in Patients With Irritable Bowel Syndrome
Official Title Colonoscopy-related Pain Predicts the Treatment Response of Amitriptyline in Patients With Irritable Bowel Syndrome
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Irritable Bowel 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 20, 2015)
118
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2016
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02638870
Other Study ID Numbers 2015-08-109
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Poong-Lyul Rhee, Samsung Medical Center
Study Sponsor Samsung Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Poong-Lyul Rhee, M.D.,Ph.D. Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
PRS Account Samsung Medical Center
Verification Date December 2015