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Validation of Surrogate Measures in Irritable Bowel Syndrome (IBS)

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ClinicalTrials.gov Identifier: NCT00693732
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : January 7, 2014
Sponsor:
Collaborator:
NMRC, Singapore
Information provided by (Responsible Party):
Medicine, National University Hospital, Singapore

Tracking Information
First Submitted Date  ICMJE June 5, 2008
First Posted Date  ICMJE June 9, 2008
Last Update Posted Date January 7, 2014
Study Start Date  ICMJE February 2009
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2011)
To correlate clinical measures of IBS activity with experimental measures of central sensitisation and endogenous pain modulation [ Time Frame: 3 years ]
  1. To correlate clinical measures of IBS activity with experimental measures of central sensitisation and endogenous pain modulation over the course of six months
  2. To correlate changes in brain and brainstem activation patterns in a subgroup of 15 patients and 15 controls by functional MRI with clinical IBS activity, symptom and pain scores, experimental measures of central sensitisation and endogenous pain modulation over the course of six months.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of Surrogate Measures in Irritable Bowel Syndrome (IBS)
Official Title  ICMJE Validation of Surrogate Measures in Irritable Bowel Syndrome (IBS)
Brief Summary Visceral and somatic hypersensitivity as evidence of central sensory sensitization occur in the majority of Irritable Bowel Syndrome (IBS) patients. We recently demonstrated abnormal endogenous pain modulation as a cause of the sensitization in IBS and identified the underlying dysfunctional neuromatrix using functional MR-imaging (fMRI). Endogenous pain mechanisms regulate, fine-tune and integrate sensory and homeostatic, including neuroendocrine, immune and autonomic nervous system processes. Specific measures of sensitization and endogenous pain modulation correlate with clinical measures of somatic and neuropathic pain, suggesting usefulness as surrogate markers for clinical pain outcomes. Validation of experimental measures as surrogate markers in IBS would provide a considerable advance in pathophysiological and therapeutic research in this pharmacoeconomically burdensome disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • Drug: Escitalopram treatment
    On study inclusion at Visit 2, patients will be successively randomised using a computer generated randomisation list to either placebo or escitalopram (Lundbeck Export A/S, Singapore) 10mg given at bedtime in the first 2 weeks, followed by 20mg in the next 6 weeks. The treatments will be identical in appearance and will be administered in double-blind fashion. Treatment with any anticoagulants, antidiabetics, antimigraine drugs, antispasmodics, analgesics, psychoactive agents including antidepressants, Zelmac®, TCM or acupuncture for IBS and any drugs affecting nociception as judged by investigator are prohibited during the entire study.
    Other Name: Lexapro
  • Behavioral: Quantitative sensory testing
    Rectal Distention Stimulation
Study Arms  ICMJE
  • Active Comparator: 1, IBS patients
    Interventions:
    • Drug: Escitalopram treatment
    • Behavioral: Quantitative sensory testing
  • Experimental: 2,Healthy controls
    Interventions:
    • Drug: Escitalopram treatment
    • Behavioral: Quantitative sensory testing
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2011)
30
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

IBS patients:

  • One hundred fifty male and female IBS patients (Rome III criteria), aged 18 to 70 years, recruited from primary and secondary care via advertisements and referral networks.
  • Minimum IBS symptom rating of 75 in IBS severity scoring system (IBS-SSS) in last two weeks.
  • IBS discomfort or pain must have been patient's most prominent symptom.
  • A minimum of 40 patients each IBS-constipated (IBS-C) and IBS-diarrhoeic (IBS-D) (Rome III) to be included.
  • Patients must have been off all IBS and analgesic medication and any drugs potentially influencing sensory function for at least two weeks before study start.

Healthy controls:

  • Fifteen healthy controls aged 18 to 70 years without any gastrointestinal pathology or history of significant abdominal pain, bowel disorders, bloating or discomfort during the last 3 months.

Exclusion Criteria:

Exclusion criteria for both IBS patients and healthy controls:

  • Organic gastrointestinal or other significant systemic disease, including cardiovascular, psychiatric, neurological and endocrine diseases, as judged by investigator
  • Chronic or acute pain, except related to other functional syndromes (functional dyspepsia, chronic pelvic pain, fibromyalgia, migrane)
  • Bowel resections (except appendectomy)
  • Multiple abdominal operations, excluding hysterectomy
  • History of brain disease or brain surgery
  • Ongoing treatment with any anticoagulants, antidiabetics, antimigraine drugs, antispasmodics, analgesics, psychoactive agents including antidepressants, Zelmac®, TCM or acupuncture for IBS and any drugs affecting nociception as judged by investigator within last 14 days
  • Treatment with any investigational drug during the preceding 30 days
  • Pregnancy or lactation.
  • Claustrophobia
  • Metal implants in body (fMRI exclusion criterion)
  • No written informed consent obtained from subject
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00693732
Other Study ID Numbers  ICMJE D/06/264
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medicine, National University Hospital, Singapore
Study Sponsor  ICMJE National University Hospital, Singapore
Collaborators  ICMJE NMRC, Singapore
Investigators  ICMJE Not Provided
PRS Account National University Hospital, Singapore
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP