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Chloride Channel Activator
Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
Phase 3
Waitlist Available
Research Sponsored by Mallinckrodt
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 week 1
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Summary
To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.
Eligible Conditions
- Chronic Constipation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Spontaneous Bowel Movements (SBMs) Within 1 Week
Secondary study objectives
Consistency of SBMs at Week 1
Mean Change From Baseline in Stool Consistency at Week 1
Mean Change From Baseline in Straining at Week 1
+2 moreSide effects data
From 2008 Phase 4 trial • 127 Patients • NCT0045233515%
Vomiting
11%
Diarrhoea
7%
Abdominal pain
4%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
12 mcg QD
12 mcg BID
24 mcg BID
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.
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: LubiprostoneExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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?
MallinckrodtLead Sponsor
201 Previous Clinical Trials
15,702 Total Patients Enrolled
Sucampo Pharma Americas, LLCIndustry Sponsor
17 Previous Clinical Trials
5,046 Total Patients Enrolled
TakedaIndustry Sponsor
1,240 Previous Clinical Trials
4,147,513 Total Patients Enrolled
Sucampo AGIndustry Sponsor
4 Previous Clinical Trials
1,316 Total Patients Enrolled
Global Clinical LeaderStudy DirectorMallinckrodt
165 Previous Clinical Trials
81,312 Total Patients Enrolled