Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo

Sucampo

Status and phase: Completed; Phase 3

Conditions: Chronic Idiopathic Constipation

Treatments: Drug: Lubiprostone; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03097861

SCMP-0211-302

Details and patient eligibility

About

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).

Enrollment: 552 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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552 participants in 3 patient groups, including a placebo group

Lubiprostone Capsule

Active Comparator group

Description:

Lubiprostone 24 mcg capsule twice daily (BID) for 7 days.

Treatment:

Drug: Lubiprostone

Lubiprostone Sprinkle

Experimental group

Description:

Lubiprostone 24 mcg sprinkle BID for 7 days.

Treatment:

Drug: Lubiprostone

Placebo

Placebo Comparator group

Description:

Placebo matching to lubiprostone (sprinkle/capsule) BID for 7 days.

Treatment:

Drug: Placebo