# Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability

> **NCT00986258** · PHASE3 · TERMINATED · sponsor: **Grünenthal GmbH** · enrollment: 136 (actual)

## Conditions studied

- Pain
- Chronic Pain
- Low Back Pain
- Neuropathic Pain
- Nociceptive Pain

## Interventions

- **DRUG:** Tapentadol Prolonged Release

## Key facts

- **NCT ID:** NCT00986258
- **Lead sponsor:** Grünenthal GmbH
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2009-10-30
- **Primary completion:** 2010-12
- **Final completion:** 2011-01
- **Target enrollment:** 136 (ACTUAL)
- **Why stopped:** This clinical trial was terminated early, due to slow recruitment and study drug shortages.
- **Last updated:** 2019-01-09


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00986258

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00986258, "Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability". Retrieved via AI Analytics 2026-06-03 from https://api.ai-analytics.org/clinical/NCT00986258. Licensed CC0.

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