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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00067561




Registration number
NCT00067561
Ethics application status
Date submitted
21/08/2003
Date registered
25/08/2003
Date last updated
16/04/2015

Titles & IDs
Public title
Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
Scientific title
A Twelve-Week, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of 0.5 mg QD, 1 mg QD and 1 mg BID of Alosetron in Female Subjects With Severe Diarrhea-predominant IBS Who Have Failed Conventional Therapy
Secondary ID [1] 0 0
S3B30040
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Irritable Colon 0 0
Irritable Bowel Syndrome (IBS) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alosetron

Treatment: Drugs: Alosetron
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Comparison of treatment groups with respect to subject relief of IBS pain & discomfort.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).

- Failed conventional therapy.

- Willing to make daily calls on a touch-tone telephone.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- History of or current chronic or severe constipation.

- Bloody diarrhea, abdominal pain with rectal bleeding.

- Thrombophlebitis.

- Abnormal thyroid stimulating hormone (TSH) value.

- Alcohol and/or substance abuse within past two years.

- Pregnant or lactating.

- History/treatment of malignancy within past five years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2005
Sample size
Target
Accrual to date
Final
702
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
27408 - Nedlands
Recruitment outside Australia
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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Montana
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New Hampshire
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Wisconsin

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to compare the safety and effectiveness of different doses of an
investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome
(IBS) who have failed conventional therapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00067561
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00067561