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NCT01056315 · ClinicalTrials.gov registry record · Phase 2

A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y

A Phase 2 study, sponsored by Grünenthal.

Terminated
Registry status
Phase 2
Development phase
553
Enrollment target

NCT01056315: Clinical Trial Phase 2 study, sponsored by Grünenthal.

NCT01056315 is a Phase 2 study that was terminated before completion, run by Grünenthal. The registered enrollment target is 553 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (316% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01056315, a Phase 2 study, was terminated before completion, sponsored by Grünenthal.

TERMINATED
Registry status
Phase 2
Development phase
553 participants
Enrollment target

Study Summary

This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN).

Primary Outcome

The primary efficacy endpoint is the change from baseline in the mean of the daily average pain intensity scores (on an 11-point NRS) over the last 7 days of the 12-week maintenance (Week 16).

Interventions

  • DRUG Placebo
  • DRUG GRT3938Y

Trial Details

FieldValue
Enrollment Target 553 participants
Start Date 2009-11
Est. Completion 2011-01
Phase Phase 2
Grünenthal

16 total trials

Why NCT01056315 stopped before completion

NCT01056315 is an interventional study that assigns participants to a tested intervention. The registered 553 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 (316% higher).

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

NCT01056315 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01056315 about?

NCT01056315 is a clinical study titled "A Trial in Painful Diabetic Peripheral Neuropathy With GRT3983Y". This trial is assessing the analgesic efficacy and safety of a new central analgesic in subjects with pain due to diabetic peripheral neuropathy (DPN).

What is the current status of trial NCT01056315?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 553 participants. The study started on 2009-11. Estimated completion is 2011-01.

What interventions are being tested in trial NCT01056315?

The interventions under investigation include: Placebo (DRUG), GRT3938Y (DRUG).

Who is sponsoring clinical trial NCT01056315?

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

How this trial's enrollment target compares

Where NCT01056315's enrollment target sits among peer trials

553 60th of 2000 higher than 1,941 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 NCT01056315, the US trial registry maintained by the National Library of Medicine. NCT01056315 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.