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
An Evaluation of the Effectiveness and Tolerability of Tapentadol Hydrochloride Prolonged Release, and Tapentadol Hydrochloride Immediate Release on Demand, in Subjects With Severe Chronic Nociceptive, Mixed or Neuropathic Low Back Pain Taking WHO Step III Analgesics But Showing a Lack of Tolerability
Sponsor: Grünenthal GmbH
Terminated
This clinical trial was terminated early, due to slow recruitment and study drug shortages.
Listed as NCT00986258, this PHASE3 trial focuses on Chronic Pain and Low Back Pain and remains terminated or withdrawn. Sponsored by Grünenthal GmbH, it has been updated 9 times since 2009, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
9 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE3
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Sep 2025 — Present [monthly]
Terminated PHASE3
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Sep 2024 — Sep 2025 [monthly]
Terminated PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE3
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Dec 2021 — Jul 2024 [monthly]
Terminated PHASE3
▶ Show 4 earlier versions
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Jan 2021 — Dec 2021 [monthly]
Terminated PHASE3
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Feb 2019 — Jan 2021 [monthly]
Terminated PHASE3
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Jun 2018 — Feb 2019 [monthly]
Terminated PHASE3
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Jan 2017 — Jun 2018 [monthly]
Terminated PHASE3
First recorded
Oct 2009
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Grünenthal GmbH
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Albstadt, Germany , Alkmaar, Netherlands , Basel, Switzerland , Berlin, Germany , Brno, Czechia , Bruges, Belgium , Cadiz, Spain , Charleroi, Belgium , Doetinchem, Netherlands , Edegem, Belgium and 15 more locations