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NCT01053962 · ClinicalTrials.gov registry record · Phase 2
SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation
A Phase 2 study of Chronic Idiopathic Constipation, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
- 14
- Study locations
NCT01053962: Completed Phase 2 study of Chronic Idiopathic Constipation, sponsored by Bausch Health Americas.
NCT01053962 is a Phase 2 study of Chronic Idiopathic Constipation that has completed, run by Bausch Health Americas. The registered enrollment target is 84 participants, below the 760-participant average among 6 other Chronic Idiopathic Constipation trials with a reported enrollment target (89% lower). The trial reports 14 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01053962, a Phase 2 study of Chronic Idiopathic Constipation, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
- 14
- Study locations
Study Summary
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.
Primary Outcome
Incidences of adverse events from Baseline through the end of the Follow-up period.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SP-304 0.3 mg
- DRUG SP-304 1.0 mg
- DRUG SP-304 3.0 mg
- DRUG SP-304 9.0 mg
Study Locations (14)
Arizona
- Novara Clinical Research - Mesa
- Genova Clinical Research - Tucson
California
- Advanced Clinical Research - Anaheim
- Advanced Clinical Research - Orange
Florida
- A.G.A. Clinical Trials - Hialeah
- Miami Ressearch and Associates - Miami
North Carolina
- Universtiy of North Carolina at Chapel Hill - Chapel Hill
- Wake Research Associates - Raleigh
Tennessee
- Memphis Gastroenterology Group - Germantown
- Nashville Medical Research Institute - Nashville
Texas
- DCOL Center for Clinical Research - Longview
- Pioneer Research Solutions - Sugar Land
Kansas
- Lee Research Institute - Shawnee Mission
Michigan
- Clinical Research Institute of Michigan, LLC - Chesterfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2010-03 |
| Est. Completion | 2010-08 |
| Phase | Phase 2 |
What the finished NCT01053962 record still lists
NCT01053962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 760-participant average among 6 other Chronic Idiopathic Constipation trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Chronic Idiopathic Constipation appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT01053962 lists 14 locations in 8 states (Arizona, California, Florida).
Frequently Asked Questions
What is clinical trial NCT01053962 about?
NCT01053962 is a clinical study titled "SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation". 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.
What is the current status of trial NCT01053962?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2010-03. Estimated completion is 2010-08.
What conditions does trial NCT01053962 study?
This clinical trial studies the following conditions: Chronic Idiopathic Constipation.
What interventions are being tested in trial NCT01053962?
The interventions under investigation include: Placebo (DRUG), SP-304 0.3 mg (DRUG), SP-304 1.0 mg (DRUG), SP-304 3.0 mg (DRUG), SP-304 9.0 mg (DRUG).
Who is sponsoring clinical trial NCT01053962?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01053962 being conducted?
This trial has 14 study locations across Arizona, California, Florida, Kansas, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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