SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Idiopathic Constipation

In brief

This is a Phase 2a, randomized, double-blind, placebo-controlled, 14-day repeat oral, dose ranging study to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) effects of SP-304 in patients with chronic idiopathic constipation.

Key facts

Study ID

NCT01053962

Run by

Bausch Health Americas, Inc.

People needed

84

Starts

2010-03-01

Expected to finish

2010-08-01

Last updated by the study team

2020-01-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is able to understand and willing to sign the Informed Consent Form (ICF) and capable of providing written authorization for use and disclosure of protected health information per requirements of 45 CFR 164.508 (Health Insurance Portability and Accountability Act [HIPAA]).
• Subject is male or non-pregnant, non-breastfeeding female, between 18 and 75 years of age (inclusive) at the time of first dose.
• Subject has a body mass index (BMI) between 18 and 35 kg/m2.
• Subject meets the Rome III Diagnostic Criteria for constipation (Drossman, 2006) for the past 3 months with symptom onset > 6 months prior to diagnosis.

You may not qualify if…

• Subject reports loose stool (fluffy pieces with ragged edges, a mushy stool) or watery stool (no solid pieces, entirely liquid; BSFS score of 6 or 7, respectively) in the absence of any laxative, enema, suppository or prohibited medicine for > 25% of BMs during the 3 months prior to the Screening visit and during the 14 day pre-treatment period.
• Subjects who meet the Rome III criteria for IBS.
• Subject has failed to complete the pre-treatment bowel movement diary accurately and completely during the pre-treatment period prior to Day 1 dosing.

Where it is running

• Novara Clinical Research — Mesa, Arizona, United States
• Genova Clinical Research — Tucson, Arizona, United States
• Advanced Clinical Research — Anaheim, California, United States
• Advanced Clinical Research — Orange, California, United States
• A.G.A. Clinical Trials — Hialeah, Florida, United States
• Miami Ressearch and Associates — Miami, Florida, United States
• Lee Research Institute — Shawnee Mission, Kansas, United States
• Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
• Universtiy of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Memphis Gastroenterology Group — Germantown, Tennessee, United States
• Nashville Medical Research Institute — Nashville, Tennessee, United States
• DCOL Center for Clinical Research — Longview, Texas, United States
• Pioneer Research Solutions — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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