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Validation of Surrogate Measures in Irritable Bowel Syndrome (IBS)
This study is not yet open for participant recruitment.
Verified by National University Hospital, Singapore, June 2008
Sponsored by: National University Hospital, Singapore
Information provided by: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00693732
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Escitalopram treatment
Behavioral: Quantitative sensory testing
Procedure: Corticotrophin-releasing hormone stimulation
Phase IV

Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Corticotropin Corticotropin-releasing hormone
U.S. FDA Resources
Study Type: Interventional
Official Title: Validation of Surrogate Measures in Irritable Bowel Syndrome (IBS)

Further study details as provided by National University Hospital, Singapore:

Arms Assigned Interventions
1, IBS patients: Active Comparator Drug: Escitalopram treatment Behavioral: Quantitative sensory testing Procedure: Corticotrophin-releasing hormone stimulation
2,Healthy controls: Experimental Drug: Escitalopram treatment Behavioral: Quantitative sensory testing Procedure: Corticotrophin-releasing hormone stimulation

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693732

Contacts
Contact: Clive H Wilder-Smith, M.D 6772 ext 4112 cws@braingut. com

Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
  More Information

Study ID Numbers: D/06/264
Study First Received: June 5, 2008
Last Updated: June 6, 2008
ClinicalTrials.gov Identifier: NCT00693732  
Health Authority: Singapore: Domain Specific Review Boards

Study placed in the following topic categories:
Digestive System Diseases
Corticotropin-Releasing Hormone
Gastrointestinal Diseases
Colonic Diseases
Irritable Bowel Syndrome
Dexetimide
Intestinal Diseases
Citalopram
Colonic Diseases, Functional
Serotonin
Adrenocorticotropic Hormone

Additional relevant MeSH terms:
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Psychotropic Drugs
Hormones
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Pathologic Processes
Syndrome
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009