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NCT01122030 · ClinicalTrials.gov registry record · Phase 2

Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain

A Phase 2 study, sponsored by Shionogi.

Completed
Registry status
Phase 2
Development phase
72
Enrollment target

NCT01122030 is a Phase 2 study that has completed, run by Shionogi. The registered enrollment target is 72 participants.

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The verdict

NCT01122030, a Phase 2 study, has completed, sponsored by Shionogi.

COMPLETED
Registry status
Phase 2
Development phase
72 participants
Enrollment target

Study Summary

The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.

Interventions

  • DRUG Placebo
  • DRUG Naldemedine

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2010-05-19
Est. Completion 2011-03-22
Phase Phase 2

Sponsor

Shionogi

54 total trials

What the Registry Record Tells You About NCT01122030

The ClinicalTrials.gov registry entry for NCT01122030 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shionogi, which has 54 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01122030 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01122030 about?

NCT01122030 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Naldemedine (S-297995) for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Pain". The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.

What is the current status of trial NCT01122030?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2010-05-19. Estimated completion is 2011-03-22.

What interventions are being tested in trial NCT01122030?

The interventions under investigation include: Placebo (DRUG), Naldemedine (DRUG).

Who is sponsoring clinical trial NCT01122030?

This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.

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

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.