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NCT01043263 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain

A Phase 2 study, sponsored by Grünenthal.

Completed
Registry status
Phase 2
Development phase
236
Enrollment target

NCT01043263: Completed Phase 2 study, sponsored by Grünenthal.

NCT01043263 is a Phase 2 study that has completed, run by Grünenthal. The registered enrollment target is 236 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01043263, a Phase 2 study, has completed, sponsored by Grünenthal.

COMPLETED
Registry status
Phase 2
Development phase
236 participants
Enrollment target

Study Summary

The purpose of this study is to determine the efficacy and safety of EN3324 (axomadol) in subjects with moderate to severe chronic low back pain

Interventions

  • DRUG Placebo
  • DRUG EN3324 (axomadol)

Trial Details

FieldValue
Enrollment Target 236 participants
Start Date 2009-12
Est. Completion 2011-06
Phase Phase 2
Grünenthal

16 total trials

What the finished NCT01043263 record still lists

NCT01043263 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% higher).

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

NCT01043263 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01043263 about?

NCT01043263 is a clinical study titled "Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain". The purpose of this study is to determine the efficacy and safety of EN3324 (axomadol) in subjects with moderate to severe chronic low back pain

What is the current status of trial NCT01043263?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 236 participants. The study started on 2009-12. Estimated completion is 2011-06.

What interventions are being tested in trial NCT01043263?

The interventions under investigation include: Placebo (DRUG), EN3324 (axomadol) (DRUG).

Who is sponsoring clinical trial NCT01043263?

This trial is sponsored by Grünenthal, which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01043263's enrollment target sits among peer trials

236 255th of 2000 higher than 1,746 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01043263, the US trial registry maintained by the National Library of Medicine. NCT01043263 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.