Last updated: 11/07/2018 18:34:45
A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Alosetron Hydrochloride 1mg Twice Daily for Control of Bowel Urgency in Females with Non-constipated Irritable Bowel Syndrome in an Independent Practitioner Association (IPA) Model
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Alosetron Hydrochloride 1mg Twice Daily for Control of Bowel Urgency in Females with Non-constipated Irritable Bowel Syndrome in an Independent Practitioner Association (IPA) Model
Trial description: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Tolerability of Alosetron Hydrochloride 1mg Twice Daily for Control of Bowel Urgency in Females with Non-constipated Irritable Bowel Syndrome in an Independent Practitioner Association (IPA) Model
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Abstract: Global improvement and satisfactory control of bowel urgency in irritable bowel syndrome (ibs) patients treated with alosetron hydrochloride (lotronexâ®). Ameen, Vanessa, Gordon, Susan, and Carter, Eric Digestive Disease Week 2003: American Association for the Study of Liver Diseases, American Gastroenterological Association, American Society for Gastrointestinal Endoscopy, Society for Surgery of the Alimentary Tract 5/17/2003 Orlando, FL; USA
Abstract: Satisfactory control of bowel urgency and global improvement in irritable bowel syndrome (ibs) with lotronex (alosetron hcl) therapy. Markowits, M S, Bagby, B S, Gordon, S, Decker, C, Jhingran, P, and Carter, E American College of Gastroenterology 65th Annual Scientific Meeting/Postgraduate American College of Gastroenterology Annual Postgraduate Gastroenterology Course & 65th Annual Scientific Meeting 10/12/2000 New York, NY; USA
Control of Bowel Urgency and Global Symptom Improvement by Alosetron in Women with Severe Diarrhea-Predominant Irritable Bowel Syndrome T Lembo, K Olden, S Gordon, V Ameen, A Heath, E Carter; Clinical Gastro Hepatology, August issue
Effect of Alosetron on Bowel Urgency and Global Symptoms in Women with Severe Diarrhea-Predominant Irritable Bowel Syndrome: Analysis of Two Controlled Trials, T Lembo, K Olden,V Ameen, S Gordon, A Heath, E Carter, Clin Gastro and Hepatol,2(8):675-82,2004.
Global Improvement and Satisfactory Control of Bowel Urgency in Female Irritable Bowel Syndrome (IBS) Patients Treated With Alosetron Hydrochloride (Lotronex®) , V Ameen, S Gordon, E Carter, Gastroenterology 124 (4) Supp1: A397, 2003
Validation of the IBS Global Improvement Scale: An Integrated Symptom Endpoint for Assessing Treatment Efficacy, Gordon S, Ameen V, Bagby B, Shahan B, Jhingran P, Carter, E, Dig Dis Sci, 48 (7): 1317-1323, 2003
Medical condition
Irritable Colon
Product
alosetron
Collaborators
Not applicable
Study date(s)
March 2000 to March 2001
Type
Not applicable
Phase
4
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2001-02-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Not applicable
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