Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain
CompletedPhase 2NCT01043263
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- Official title
- A Phase IIB, Randomized, Double-blind, Two-arm, Multi-center, Placebo-controlled, Study to Assess the Efficacy and Safety of EN3324 (Axomadol) in Subjects With Moderate to Severe Chronic Low Back Pain
- Conditions
- Interventions
- Drug: EN3324 (axomadol)
- Drug: Placebo
- Sponsor
- Grünenthal GmbH
- Start date
- 2009-12
- Primary completion
- 2011-06
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 59
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 18 years of age or older * Are females who are participating abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year. * Have been on an unchanged regimen of analgesic medication for chronic low back pain on a daily basis for at least 3 months prior to screening; subjects taking opioids must not exceed total daily doses of 90mg oral morphine equivalent * Have a history of moderate to severe CLBP Exclusion Criteria: * Have evidence of or a history of alcohol and/or drug abuse * Have pain secondary to a confirmed or suspected neoplasm * Intend to alter their physical therapy regimen during the study. Subjects who begin or end physical therapy (either home exercises or formal therapy sessions) 2 weeks prior to screening or during the study period will be excluded from the study * Have a history or physical examination finding, which may confound pain-related data (e.g., fibromyalgia, radiculopathy)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01043263