Irritable ColonPhase 4NCT00370032

Study to Assess the Effect Of Alosetron On Mucosal Blood Flow

A Phase 4 study testing alosetron in people with Irritable Colon, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for: Irritable Colon
What is being tested?: alosetron
How many people: 49 participants
Where: 1 siteUnited Kingdom
Study dates: Dec 2006to Dec 2007
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.
OR
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.

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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).

Who cannot join

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):

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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
gastrointestinal adhesions
ischemic colitis
toxic megacolon
impaired intestinal circulation
gastrointestinal perforation
gastrointestinal obstruction and/or stricture
Ischemic cardiovascular conditions:
coronary artery disease (CAD)
significant atherosclerosis
chronic pancreatitis
diabetes
thrombophlebitis or hypercoagulable state.
Current evidence of (within the past 6 months):
diverticulitis
ileus
symptomatic cholelithiasis
proctitis.
Current evidence of:
Hemoccult (+) stool.
The subject has a BMI of ≥27.
Mental impairment or inability or refusal to follow directions.
The subject has current evidence of, or has been treated for a malignancy within the past five years (other than localized basal cell, squamous cell skin cancer or cancer in situ that has been resected).
The subject exhibits evidence of hepatic dysfunction, viral hepatitis, or exhibits serum ALT (alanine aminotransferase) (SGPT), AST (aspartate aminotransferase) (SGOT) values >2.5 times the upper limit of normal or alkaline phosphatase or bilirubin values >2.0 times the upper limit of normal.
The subject displays renal impairment as evidenced by a serum creatinine value >2.0 mg/dl.
The subject has used any medication within the seven days prior to dosing, unless approved by the investigator and GlaxoSmithKline (GSK) personnel. Section 9.1.
The subject has used an investigational drug, or participated in an investigational study, within 30 days of the Screening Visit.
The subject has a history of drug allergies (including but not limited to hypersensitivity responses to alosetron which, in the opinion of the investigator, contraindicates the subject's participation in this study.
Subjects who have made a blood donation (>450mL) within 6 weeks prior to screening.
The subject has a history of alcohol and/or substance abuse within the past two years.
The subject is pregnant. The subject is breastfeeding.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
London, W1G 8HU

Other trials in United Kingdom

About this study

Official title: A Randomize, Placebo-controlled, Crossover Study to Measure the Effect of Alosetron on Mucosal Blood Flow in Female Healthy Volunteers and Diarrhea-predominant IBS Subjects

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
Being tested: alosetron
Keywords: mucosal blood flow d-IBS
Medical subject headings: Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

alosetronDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 6 after each treatment period

Secondary outcomes (2)

Rectal Mucosal Blood Flow (MBF)
On Day 6 of each treatment period approximately 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There was no pre-treatment LDF procedure, MBF was compared between the Healthy and d-IBS cohorts using the flow rates from the placebo treatment period.
Measured: Day 6 after each treatment period
Left Colon and Rectal Mucosal Blood Flow Cohort Comparisons
On Day 6 of each treatment period approximately 1 hour after dosing, subjects underwent a flexible sigmoidoscopy with Laser Doppler Flowmetry (LDF) to measure Mucosal Blood Flow (MBF). There was no pre-treatment LDF procedure, MBF was compared between the Healthy and d-IBS cohorts using the flow rates from the placebo treatment period.
Measured: Day 6 after each treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Dec 2007

First posted30 Aug 2006 (estimated)
Study startDec 2006
Primary completionDec 2007
Study completionDec 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Irritable ColonStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00370032
Sponsor's protocol ID: S3B40042
Status last verified: May 2015
First submitted: 28 Aug 2006
Last updated: 18 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea

All Irritable Colon trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomize, Placebo-controlled, Crossover Study to Measure the Effect of Alosetron on Mucosal Blood Flow in Female Healthy Volunteers and Diarrhea-predominant IBS Subjects
ClinicalTrials.gov ID: NCT00370032
Acronym / sponsor ID: S3B40042
Conditions: Irritable Colon
Keywords: mucosal blood flow d-IBS
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 30 Aug 2006 (estimated)
Results: Posted 2 Apr 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind

Who may qualify

Ages: 18 to 49 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (15 listed)

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:
OR
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.

Key exclusion criteria (45 listed)

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):

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
alosetron	Drug	–

Primary outcome

Left Colon Mucosal Blood Flow (MBF)
Time frame: Day 6 after each treatment period
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.

2 secondary outcomes

Rectal Mucosal Blood Flow (MBF)
Time frame: Day 6 after each treatment period
Left Colon and Rectal Mucosal Blood Flow Cohort Comparisons
Time frame: Day 6 after each treatment period

Results and safety

Results posted to the registry on 2 Apr 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
d-IBS (Diarrhea Predominant - Irritable Bowel Syndrome)	24	24
Healthy Volunteers	25	24

Primary outcome: Left Colon Mucosal Blood Flow (MBF)

Time frame: Day 6 after each treatment period. Mean (Standard Deviation). Unit: ml per minute per 100 grams of tissue

Measure	d-IBS Placebo n = 22	d-IBS Alosetron n = 22	Healthy Volunteers Placebo n = 19	Healthy Volunteers Alosetron n = 19
Value	125.6 (38.6)	117.5 (37.71)	130.7 (40.12)	121.6 (51.26)

d-IBS Placebo vs d-IBS Alosetron: Mean Difference (Final Values): -8.1 (95% CI -18.4 to 2.157), p = 0.131, paired t-test Hommel-Simes
Healthy Volunteers Placebo vs Healthy Volunteers Alosetron: Mean Difference (Final Values): -9.11 (95% CI -21.2 to 2.997), p = 0.131, paired t-test Hommel-Simes

Population analysed: Per Protocol Population - the population used for the primary and secondary outcome analyses. The population consisted of all randomized subjects who completed the study with MBF measurements for both treatment periods.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
d-IBS Placebo	0 of 24 (0%)	12 of 24 (50%)	Not reported
d-IBS Alosetron	0 of 23 (0%)	10 of 23 (43.5%)	Not reported
Healthy Volunteers Placebo	0 of 24 (0%)	11 of 24 (45.8%)	Not reported
Healthy Volunteers Alosetron	0 of 23 (0%)	11 of 23 (47.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Irritable Colon

RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing alosetron in people with Irritable Colon, run by GlaxoSmithKline at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 45 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left Colon Mucosal Blood Flow (MBF) (time frame: Day 6 after each treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00370032.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2015.