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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 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.

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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.

Conditions Studied

Chronic Idiopathic Constipation

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

FieldValue
Enrollment Target 84 participants
Start Date 2010-03
Est. Completion 2010-08
Phase Phase 2

Sponsor

Bausch Health Americas

168 total trials

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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, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 760-participant average among 6 other Chronic Idiopathic Constipation trials with a reported enrollment target (89% lower). The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.

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 reports 14 study locations spanning 8 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.