Phase 3
Completed N=552
Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
Chronic Idiopathic Constipation
Source: ClinicalTrials.gov NCT03097861 ↗
Enrolled (actual)
552
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week — 1.38; 1.37; 1.35; 3.68 SBMs/week — p==0.0020
◆ Published Evidence
Emerging
1citation · ~0 / year
Capsule and Sprinkle Formulations of Lubiprostone Are Not Biologically Similar in Patients with Functional Constipation.
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).
Linked Publications
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Capsule and Sprinkle Formulations of Lubiprostone Are Not Biologically Similar in Patients with Functional Constipation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week |
1.38; 1.37; 1.35; 3.68; 4.82; 5.74 | =0.0020 sig |
| SECONDARY Mean SBM Consistency Score Within 1 Week |
2.47; 2.39; 2.28; 3.43; 3.94; 4.22 | — |
| SECONDARY Mean SBM Straining Score Within 1 Week |
2.39; 2.31; 2.40; 1.76; 1.45; 1.19 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
21; 40; 73 | — |
Eligibility Criteria
Inclusion Criteria
- Either has medically-confirmed diagnosis of chronic constipation (per Rome III), or meets the diagnosis as confirmed using the Rome III constipation module questionnaire during the Screening period.
- Is male or female, 18 or older years of age
- Should be on stable dose of fiber supplement or a concomitant medication for the indication of lowering blood pressure
Exclusion Criteria
- Has any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation
- Is unable to eat or drink, take oral medications, or to hold down oral medications due to vomiting
Data sourced from ClinicalTrials.gov (NCT03097861) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.