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Chloride Channel Activator

Lubiprostone Sprinkle for Chronic Constipation

Phase 3
Waitlist Available
Research Sponsored by Sucampo Pharma Americas, LLC
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 from first dose of study medication to follow-up (up to 15 days)
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial

Summary

The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).

Eligible Conditions
  • Chronic Constipation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study medication to follow-up (up to 15 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study medication to follow-up (up to 15 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week
Secondary study objectives
Mean SBM Consistency Score Within 1 Week
Mean SBM Straining Score Within 1 Week
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Side effects data

From 2008 Phase 4 trial • 127 Patients • NCT00452335
15%
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

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Lubiprostone SprinkleExperimental Treatment1 Intervention
Lubiprostone 24 mcg sprinkle BID for 7 days.
Group II: Lubiprostone CapsuleActive Control1 Intervention
Lubiprostone 24 mcg capsule twice daily (BID) for 7 days.
Group III: PlaceboPlacebo Group1 Intervention
Placebo matching to lubiprostone (sprinkle/capsule) BID for 7 days.
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?

Sucampo Pharma Americas, LLCLead Sponsor
17 Previous Clinical Trials
4,658 Total Patients Enrolled
Sucampo AGIndustry Sponsor
4 Previous Clinical Trials
928 Total Patients Enrolled
Sucampo Pharmaceuticals, Inc.Industry Sponsor
10 Previous Clinical Trials
2,133 Total Patients Enrolled
~64 spots leftby Dec 2025
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