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NCT01965158 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation

A Phase 3 study of Opioid-induced Constipation, sponsored by Shionogi.

Completed
Registry status
Phase 3
Development phase
547
Enrollment target
20
Study locations

NCT01965158 is a Phase 3 study of Opioid-induced Constipation that has completed, run by Shionogi. The registered enrollment target is 547 participants, below the 7,123-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT01965158, a Phase 3 study of Opioid-induced Constipation, has completed, sponsored by Shionogi.

COMPLETED
Registry status
Phase 3
Development phase
547 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.

Conditions Studied

Opioid-induced Constipation

Interventions

  • DRUG Placebo
  • DRUG Naldemedine

Study Locations (20)

Florida

  • Shionogi Research Site - Miami
  • Shionogi Research Site - Miami Springs
  • Shionogi Research Site - Orlando
  • Shionogi Research Site - Sarasota
  • Shionogi Research Site - West Palm Beach
  • Shionogi Research Site - Winter Park

California

  • Shionogi Research Site - Fresno
  • Shionogi Research Site - Long Beach
  • Shionogi Research Site - National City
  • Shionogi Research Site - North Hollywood
  • Shionogi Research Site - Oceanside

Michigan

  • Shionogi Research Site - Caro
  • Shionogi Research Site - Flint

Alabama

  • Shionogi Research Site - Birmingham

Arizona

  • Shionogi Research Site - Phoenix

Colorado

  • Shionogi Research Site - Golden

Georgia

  • Shionogi Research Site - Marietta

Louisiana

  • Shionogi Research Site - Shreveport

Trial Details

FieldValue
Enrollment Target 547 participants
Start Date 2013-08-29
Est. Completion 2015-01-22
Phase Phase 3

Sponsor

Shionogi

54 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01965158

The ClinicalTrials.gov registry entry for NCT01965158 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 547 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,123-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (92% lower). The listed sponsor is Shionogi, which has 54 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Opioid-induced Constipation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01965158 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Florida, California, Michigan.

Frequently Asked Questions

What is clinical trial NCT01965158 about?

NCT01965158 is a clinical study titled "Efficacy and Safety of Naldemedine in the Treatment of Opioid-induced Constipation". The purpose of this study is to evaluate the efficacy and safety of naldemedine in the treatment of opioid-induced constipation (OIC) in adults with non-malignant chronic pain who are not using laxatives.

What is the current status of trial NCT01965158?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 547 participants. The study started on 2013-08-29. Estimated completion is 2015-01-22.

What conditions does trial NCT01965158 study?

This clinical trial studies the following conditions: Opioid-induced Constipation.

What interventions are being tested in trial NCT01965158?

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

Who is sponsoring clinical trial NCT01965158?

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

Where is trial NCT01965158 being conducted?

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

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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.