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Sponsors and Collaborators: |
Hospital Authority, Hong Kong Novartis Pharmaceuticals |
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Information provided by: | Hospital Authority, Hong Kong |
ClinicalTrials.gov Identifier: | NCT00563615 |
Functional constipation is a common problem in Hong Kong. In a recent telephone survey, the prevalence of constipation as defined by Rome II criteria was 14%. Apart from organic, metabolic, neurological and drug induced causes, constipation most often arises from 2 disorders of colorectal motility: slow transit constipation or pelvic floor dysfunction or both. In the position statement from the American Gastroenterological Association , colon transit study was recommended to differentiate slow transit constipation from pelvic floor dysfunction. The management algorithm for normal transit and slow transit constipation was different and surgery should be considered for patients with slow transit constipation. In a recent paper by Bonapace , scintigraphy could be used to study both gastric, small bowel and large bowel transit time. The clinical diagnosis was changed in 51% of cases of constipation after scintigraphy and patient management such as adding a prokinetic agent, referral to biofeedback center, decision on surgery was affected in 64% of cases.
Tegaserod is a recently approved prokinetic agent to be marketed in Hong Kong for the management of patients with constipation predominant irritable bowel syndrome (C-IBS). In a paper from Mayo clinic based on scintigraphic examination, tegaserod 2mg bd accelerates orocaecal transit in C-IBS patients. However studies in functional constipation basing on tegaserod 6 mg twice daily has not been published yet. Therefore, the Gastroenterology team and nuclear medicine teams of Princess Margaret Hospital, Gastroenterology teams of Caritas Medical Center and Yan Chai Hospital decide to study small and large bowel transit in functional constipation patients by scintigraphy. The efficacy of tegaserod in improving bowel transit is also examined in this randomized double blind placebo controlled study.
Condition | Intervention |
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Constipation |
Drug: Tegaserod |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Study of Effect of Tegaserod on Small and Large Bowel Transit by Scintigraphic Method |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Note: For patients who require these procedures, these tests should be performed after the patient has signed informed consent and at least 7 days PRIOR to the start of the diaries (washout period). The 7-day window is to allow the patient to recuperate prior to collecting baseline data.
A copy of the report should be placed in the patient source document.
Exclusion Criteria:
Contact: Ambrose CP Kwan, Dr | (852) 2990 1111 | argylest@netvigator.com |
China | |
Princess Margaret Hospital | Recruiting |
Hong Kong, China | |
Sub-Investigator: King Sun Chu, Dr | |
Sub-Investigator: Ka Man Ng, Dr | |
Sub-Investigator: Wing Hang Wong, Dr | |
Sub-Investigator: Hon Yeun, Dr | |
Caritas Medical Centre | Recruiting |
Hong Kong, China | |
Sub-Investigator: Yat Wah Yeung, Dr | |
Yan Chai Hospital | Recruiting |
Hong Kong, China | |
Sub-Investigator: Wai Keung Kwan, Dr |
Principal Investigator: | Ambrose CP Kwan, Dr | Department of Medicine and Geriatrics, Unit A, Princess Margaret Hospital |
Study ID Numbers: | KW/FR/03-030, HARECCTR0500026 |
Study First Received: | November 21, 2007 |
Last Updated: | December 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00563615 |
Health Authority: | Hong Kong: Ethics Committee |
Constipation (idiopathic) |
Signs and Symptoms Signs and Symptoms, Digestive Constipation Serotonin Tegaserod |
Serotonin Agonists Neurotransmitter Agents Serotonin Agents |
Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Pharmacologic Actions |