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Sponsored by: |
National University Hospital, Singapore |
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Information provided by: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT00693732 |
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 |
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Irritable Bowel Syndrome |
Drug: Escitalopram treatment Behavioral: Quantitative sensory testing Procedure: Corticotrophin-releasing hormone stimulation |
Phase IV |
Study Type: | Interventional |
Official Title: | Validation of Surrogate Measures in Irritable Bowel Syndrome (IBS) |
Arms | Assigned Interventions |
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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 |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
IBS patients:
Healthy controls:
Exclusion Criteria:
Exclusion criteria for both IBS patients and healthy controls:
Contact: Clive H Wilder-Smith, M.D | 6772 ext 4112 | cws@braingut. com |
Singapore | |
National University Hospital | |
Singapore, Singapore, 119074 |
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 |
Digestive System Diseases Corticotropin-Releasing Hormone Gastrointestinal Diseases Colonic Diseases Irritable Bowel Syndrome Dexetimide |
Intestinal Diseases Citalopram Colonic Diseases, Functional Serotonin Adrenocorticotropic Hormone |
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 |