Study to Assess the Effect Of Alosetron On Mucosal Blood Flow

NCT00370032 | Completed Phase 4 Results

• 1 other identifier: S3B40042
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This study will look at colonic mucosal blood flow in subjects who have taken alosetron vs placebo and healthy volunteers vs diarrhea-predominant Irritable Bowel Syndrome (d-IBS) patients.

Conditions

Irritable Colon

Keywords

mucosal blood flow d-IBS

Outcome Measures

Primary Outcomes (1)

• Left Colon Mucosal Blood Flow (MBF)

  On Day 6 of each treatment period; 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There were no pre-treatment LDF procedure, MBF was compared between the Healthy volunteers and D-irritable bowel syndrome (IBS) cohorts using the flow rates from the placebo treatment period.

  Day 6 after each treatment period

Secondary Outcomes (2)

• Rectal Mucosal Blood Flow (MBF)

  Day 6 after each treatment period

• Left Colon and Rectal Mucosal Blood Flow Cohort Comparisons

  Day 6 after each treatment period

Interventions

alosetron DRUG

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject signs and dates a written informed consent form prior to the initiation of any study-related activities.
• The subject is between 18 and 49 years of age at the time of the Screening Visit.
• The subject is female and either:
• A healthy subject. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests.
• A d-IBS patient per the Rome II criteria who has a normal result from a flexible sigmoidoscopy or colonoscopy, or flexible sigmoidoscopy plus barium enema, within 2 years of the Screening visit.
• The subject demonstrates a negative urine pregnancy test result prior to investigational product administration and be either:
• Of non-childbearing potential (i.e., physiologically incapable of becoming pregnant)
• post-menopausal define as one year without menses in the absence of hormone replacement therapy.
• sterilization (via hysterectomy or bilateral tubal ligation)
• Of childbearing potential and agrees to one of the following acceptable non-hormonal contraceptive methods consistently and in accordance with both the product label and the instructions of a physician. Subjects will use effective contraceptive methods for at least one month prior to Screening and should continue to use the same contraceptive method throughout the study (Follow-up Visit).
• Complete abstinence from intercourse
• an intra-uterine device (IUD) inserted by a qualified physician, provided the IUD is not of the hormonal type and it has published data showing that the highest expected failure rate is less than 1% per year (not all IUDs meet this criterion)
• double barrier method if comprised of a spermicide with either a condom or diaphragm
• sterilization of partner The subject is ambulatory (defined as not depending exclusively on a wheelchair for mobility).

You may not qualify if:

• The subject is taking oral contraceptive or other hormonal therapy.
• The subject has a concurrent illness or disability that may affect the interpretation of clinical data, or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, autoimmune, renal, hepatic, pulmonary, endocrine, metabolic, gastrointestinal, hematologic, or neurological condition).
• The subject has constipation-predominant IBS (c-IBS) or alternating IBS per the ROME II criteria.
• The subject has current evidence of or history of chronic or severe constipation, or a history of sequelae from constipation.
• Evidence of a biochemical or structural abnormality of the digestive tract. These conditions include (but not limited to):
• Current evidence, or history of (at any time in the past):
• GI/Bowel conditions:
• inflammatory bowel disease (Crohn's disease or ulcerative colitis)
• celiac disease
• laxative abuse (in the clinical judgement of the physician)
• gastrointestinal surgery (exceptions include ≥6 months post-surgery appendectomy, cholecystectomy, fundoplication without gas bloat, or hiatal hernia repair; ≥3 months post-surgery herniorrhaphy without bowel resection)
• gastroparesis
• GI malignancy
• carcinoid syndrome
• amyloidosis

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

London, W1G 8HU, United Kingdom

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

alosetron

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2006
• First Posted: August 30, 2006
• Study Start: December 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 18, 2015
• Results First Posted: April 2, 2009

Record last verified: 2015-05

Locations

GB (1)