Last updated: 11/07/2018 18:33:59
A Twelve 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 Nonconstipated Irritable Bowel Syndrome
Clinicaltrials.gov ID
Not applicable
EudraCT ID
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EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Twelve 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 Nonconstipated Irritable Bowel Syndrome
Trial description: A Twelve 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 Nonconstipated Irritable Bowel Syndrome
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:
Carter E, Gordon S, Bagby B, Harrison C, Decker C. Laxative use in the management of constipation in Lotronex treated females with nonconstipated IBS. Am J Gastro 95(9): 2530, 2000
Gordon S, Ameen V, Bagby B, Shahan B, Jhingran P, Carter, E. Validation of the IBS Global Improvement Scale: An Integrated Symptom Endpoint for Assessing Treatment Efficacy. Dig Dis Sci, 48 (7): 1317-1323, 2003.
Jhingran P, Bagby B, Decker C, Gordon S, Markowitz M, Carter E. Patient Satisfaction in Lotronex treated nonconstipated IBS females. Am J Gastro 95(9):2631-2 , 2000
Jhingran P, Bagby B, Gordon S, Markowitz M, Thompson B, Carter E. Impact of Lotronex on workplace productivity and activity time in females with nonconstipated IBS. Am J Gastro 95(9): 2537, 2000
Lembo T, Wright R, Bagby B, et al. Alosetron controls bowel urgency and provides global symptom improvement in women with diarrhea-predominant irritable bowel syndrome. Am J Gastro 2001 Sep;96(9):2662-70.
Markowitz M, Bagby B, Gordon, Decker C, Jhingran P, Carter E. Satisfactory control of bowel urgency and global symptom improvement in IBS with Lotronex therapy. Am J Gastro 95(9): 2543, 2000
Northcutt A, Mangel A, Hamm L, et al. Validation of Global Improvement Scale in Irritable Bowel Syndrome (IBS) as an Endpoint in IBS Clinical Trials. Program and abstracts of Digestive Disease Week 2001; May 20-23, 2001; Atlanta, Georgia. Poster #3243
Olden K, DeGarmo R, Jhingran P, Bagby B, Decker C, Markowitz M, Carter, E. Patient satisfaction with alosetron for the treatment of diarrhea-predominant IBS. Am J Gastro, 97 (12) 3139-46, 2002
T Lembo, K Olden,V Ameen, S Gordon, A Heath, E Carter. Effect of Alosetron on Bowel Urgency and Global Symptoms in Women with Severe Diarrhea-Predominant Irritable Bowel Syndrome: Analysis of Two Controlled Trials. Clin Gastro and Hepatol,2(8):675-82,2004.
Medical condition
Irritable Colon
Product
alosetron
Collaborators
Not applicable
Study date(s)
August 1999 to April 2000
Type
Not applicable
Phase
3
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
2000-21-04
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
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