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COMPLETED Phase 2

Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function

NCT01280344 · View on ClinicalTrials.gov ↗

Study Summary

Post-operative administration of ipamorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial small and/or large bowel resection.

Interventions

  • DRUG Saline Solution for Injection
  • DRUG Ipamorelin

Study Locations (20)

Florida

  • — Aventura
  • — Inverness
  • — Miami
  • — Orlando
  • — Pensacola
  • — Sarasota
  • — Tampa
  • — Weston

California

  • — Fountain Valley
  • — Glendale
  • — Laguna Hills
  • — Los Angeles
  • — Orange
  • — San Francisco

Alabama

  • — Florence
  • — Sheffield

Illinois

  • — Chicago
  • — Highland Park

Colorado

  • — Aurora

Georgia

  • — Atlanta

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2011-04
Est. Completion 2014-05
Phase Phase 2

Sponsor

Helsinn Therapeutics (U.S.)

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01280344

The ClinicalTrials.gov registry entry for NCT01280344 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 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Helsinn Therapeutics (U.S.), which has 3 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 Gastrointestinal Dysmotility appearing as the primary indexed condition, and to 2 interventions — of which Saline Solution for Injection 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: NCT01280344 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, California, Alabama. 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 NCT01280344 about?

NCT01280344 is a clinical study titled "Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function". Post-operative administration of ipamorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial small and/or large bowel resection.

What is the current status of trial NCT01280344?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2011-04. Estimated completion is 2014-05.

What conditions does trial NCT01280344 study?

This clinical trial studies the following conditions: Gastrointestinal Dysmotility. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01280344?

The interventions under investigation include: Saline Solution for Injection (DRUG), Ipamorelin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01280344?

This trial is sponsored by Helsinn Therapeutics (U.S.), which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01280344 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial