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NCT01361607 · ClinicalTrials.gov registry record · Phase 3

Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer

A Phase 3 study of Pain and Advanced Cancer, sponsored by Jazz Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
399
Enrollment target
20
Study locations

NCT01361607 is a Phase 3 study of Pain and Advanced Cancer that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 399 participants, above the 303-participant average among 374 other Pain trials with a reported enrollment target (32% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT01361607, a Phase 3 study of Pain and Advanced Cancer, has completed, sponsored by Jazz Pharmaceuticals.

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

Study Summary

This 9-week study aimed to determine the efficacy, safety, and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced cancer. Eligible participants were not required to stop any of their current treatments or medications.

Conditions Studied

Pain Advanced Cancer

Interventions

  • DRUG Nabiximols
  • DRUG Placebo (GA-0034)

Study Locations (20)

Florida

  • - Clearwater
  • - Holiday
  • - Miami
  • - Stuart

Georgia

  • - Marietta
  • - Newnan
  • - Stockbridge

California

  • - Glendale
  • - Santa Rosa

Illinois

  • - Gurnee
  • - Mount Vernon

Louisiana

  • - Bossier City
  • - Shreveport

New York

  • - New York
  • - New York

Kentucky

  • - Ashland

Montana

  • - Missoula

Trial Details

FieldValue
Enrollment Target 399 participants
Start Date 2011-05-27
Est. Completion 2014-11-24
Phase Phase 3

Sponsor

Jazz Pharmaceuticals

128 total trials

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What the Registry Record Tells You About NCT01361607

The ClinicalTrials.gov registry entry for NCT01361607 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 399 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 303-participant average among 374 other Pain trials with a reported enrollment target (32% higher). The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Nabiximols is the first listed.

NCT01361607 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Georgia, California.

Frequently Asked Questions

What is clinical trial NCT01361607 about?

NCT01361607 is a clinical study titled "Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer". This 9-week study aimed to determine the efficacy, safety, and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced cancer. Eligible participants were not required to stop any of their...

What is the current status of trial NCT01361607?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 399 participants. The study started on 2011-05-27. Estimated completion is 2014-11-24.

What conditions does trial NCT01361607 study?

This clinical trial studies the following conditions: Pain, Advanced Cancer.

What interventions are being tested in trial NCT01361607?

The interventions under investigation include: Nabiximols (DRUG), Placebo (GA-0034) (DRUG).

Who is sponsoring clinical trial NCT01361607?

This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01361607 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Kentucky. 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.