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SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation
NCT01053962 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01053962
The ClinicalTrials.gov registry entry for NCT01053962 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01053962 reports 14 study locations spanning 8 distinct geographic areas — top geographies include Arizona, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01053962?
This trial is sponsored by Bausch Health Americas, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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