Chronic Low Back PainPhase 2CLBPNCT01043263
Efficacy and Safety of EN3324 (Axomadol) in Subjects With Chronic Low Back Pain
A Phase 2 study testing EN3324 (axomadol) in people with Chronic Low Back Pain, run by Grünenthal GmbH at 59 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- EN3324 (axomadol)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 236 participants
- Where
- 59 sitesUnited States
- Study dates
- Dec 2009to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
United States59 sites
Alleghany Pain Management, PC
Altoona, Pennsylvania, 16602
Advanced Clinical Research Institute
Anaheim, California, 92801
Orange County Clinical Trials, Inc.
Anaheim, California, 92801
Future Search Trials
Ausitn, Texas, 78756
Austin Diagnostic Clinic
Ausitn, Texas, 78758
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Quest Research Institute
Bingham Farms, Michigan, 48025
Beacon Clinical Research LLC
Brockton, Massachusetts, 02301
Associated Pharmaceutical Research Center, Inc.
Buena Park, California, 90620
Medex Healthcare Research, Inc.
Chicago, Illinois, 60603
Center for Pain Management Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
Catalina Research Institute, LLC
Chino, California, 91710
David Schneider, MD
Cincinnari, Ohio, 45245
Community Research
Cincinnati, Ohio, 45227
Paragon Clinical Research Inc.
Cranston, Rhode Island, 02920
Robert Wagner, MD
Crestview Hills, Kentucky, 41017
KRK Medical Research
Dallas, Texas, 75230
Avail Clinical Research
DeLand, Florida, 32720
Mountain View Clinical Research
Denver, Colorado, 80209
Prime Care Research Associates
Florissant, Missouri, 63031
Neuropsychiatric Research Center of SW Florida
Fort Myers, Florida, 33912
Paradigm Clinical Research
Garden Grove, California, 92844
Clinical Trial Network
Houston, Texas, 77074
Medex Healthcare Research
Houston, Texas, 77074
CNS Healthcare
Jacksonville, Florida, 32216
Florida Institute of Medical Research
Jacksonville, Florida, 32257
Synergy Escondido
La Mesa, California, 91942
Triwest Research Associates
La Mesa, California, 91942
Office of Danka Micheals, MD
Las Vegas, Nevada, 89128
Stephen Miller, MD
Las Vegas, Nevada, 89144
Behavioral Clinical Research, Inc.
Lauderhill, Florida, 33319
LBCCR
Long Beach, California, 90806
Pacific Institute for Med Research
Los Angeles, California, 90024
Samaritan Center for Medical Research
Los Gatos, California, 95032
North Star Medical Research, LLC
Middleburg Heights, Ohio, 44130
Synergy Research Center
National City, California, 91950
Segal Institute for Clinical Research
North Miami, Florida, 33161
CNS Health
Orlando, Florida, 32806
Compass Research
Orlando, Florida, 32806
Altas Orthopedics & Sports Medicine
Orlando, Florida, 32822
International Clinical Research Institute Inc.
Overland Park, Kansas, 66211
Four Rivers Clinical Research
Paducah, Kentucky, 42003
Matthew Doust, MD
Phoenix, Arizona, 85050
Gold Coast Research LLC.
Plantation, Florida, 33324
Finger Lakes Clinical Research
Rochester, New York, 14618
Northern California Research
Sacramento, California, 95821
Sun Research Institute
San Antonio, Texas, 78215
Medex Health Research, Inc.
St Louis, Missouri, 63117
Sundance Clinical Research
St Louis, Missouri, 63141
Bone, Joint & Spine Surgeons, Inc.
Toledo, Ohio, 43623
Neurology & Neruoscience Center of Ohio
Toledo, Ohio, 43623
Paradigm Clinical
Tucson, Arizona, 85705
Visions Clinical Research
Tucson, Arizona, 85712
Genova Clinical Research, Inc.
Tucson, Arizona, 85741
Quality of Life Medical & Research Center
Tuscon, Arizona, 85715
Omega Clinical Research
Warwick, Rhode Island, 02818
Integrated Clinical Trial Services Inc.
West Des Moines, Iowa, 50265
New Hanover Medical Research
Wilmington, North Carolina, 28401
The Center for Clinical Research, LLC & Carolinas Pain Institute, P.A.
Winstom-Salem, North Carolina, 27103
About this study
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
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
Read the detailed description
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
- Chronic Low Back Pain
- Being tested
- EN3324 (axomadol), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EN3324 (axomadol)Drug
twice daily dosing
PlaceboDrug
twice daily dosing
| Study group | Role | What they receive |
|---|---|---|
| EN3324 (axomadol) | Experimental | Not described Receives: Drug: EN3324 (axomadol) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.
Measured: Change from baseline [Day 0] to final visit [Day 112]
Secondary outcomes (2)
To evaluate the safety, tolerability and efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.
Measured: Change from baseline [Day 0] to final visit [Day 112]
To evaluate patient reported outcomes of EN3324 (axomadol) in subjects with moderate to severe CLBP.
Measured: Change from baseline [Day 0] to final visit [Day 112]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grünenthal GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043263
- Sponsor's protocol ID
- EN3324-201
- Acronym
- CLBP
- Status last verified
- Mar 2015
- First submitted
- 18 Dec 2009
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01043263
- Acronym / sponsor ID
- CLBP / EN3324-201
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Grünenthal GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EN3324 (axomadol) | Experimental | Drug: EN3324 (axomadol) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EN3324 (axomadol)twice daily dosing | Drug | EN3324 (axomadol) |
| Placebotwice daily dosing | Drug | Placebo |
Primary outcome
To evaluate the efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.
Time frame: Change from baseline [Day 0] to final visit [Day 112]
2 secondary outcomes
To evaluate the safety, tolerability and efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.
Time frame: Change from baseline [Day 0] to final visit [Day 112]
To evaluate patient reported outcomes of EN3324 (axomadol) in subjects with moderate to severe CLBP.
Time frame: Change from baseline [Day 0] to final visit [Day 112]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
59 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EN3324 (axomadol) in people with Chronic Low Back Pain, run by Grünenthal GmbH at 59 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP. (time frame: Change from baseline [Day 0] to final visit [Day 112]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2015.