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Chloride Channel Activator
Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications
Phase 4
Waitlist Available
Led By Jack A DiPalma, M.D.
Research Sponsored by University of South Alabama
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial
Summary
Constipation from medications is a serious and common condition. Lubiprostone has properties that make it a candidate drug. One hundred volunteers with constipation who are taking medications known to cause constipation will be randomized to take lubiprostone or placebo for 28 days. Therapeutic outcome will be evaluated by investigator and study subject assessment.
Eligible Conditions
- Constipation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Relief of Constipation Defined by Modified ROME Criteria
Secondary study objectives
Frequency
Side effects data
From 2009 Phase 4 trial • 60 Patients • NCT009530434%
Headache
4%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lubiprostone
Placebo
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Lubiprostone 24mcg BID for 30 daysExperimental Treatment1 Intervention
Active medication
Group II: PlaceboPlacebo Group1 Intervention
Placebo, matched, blinded
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lubiprostone
FDA approved
Find a Location
Who is running the clinical trial?
TakedaIndustry Sponsor
1,240 Previous Clinical Trials
4,147,654 Total Patients Enrolled
14 Trials studying Constipation
5,694 Patients Enrolled for Constipation
Sucampo Pharmaceuticals, Inc.Industry Sponsor
10 Previous Clinical Trials
2,662 Total Patients Enrolled
3 Trials studying Constipation
1,260 Patients Enrolled for Constipation
University of South AlabamaLead Sponsor
43 Previous Clinical Trials
15,745 Total Patients Enrolled
1 Trials studying Constipation
140 Patients Enrolled for Constipation
Jack A DiPalma, M.D.Principal InvestigatorUniversity of South Alabama College of Medicine