Low Back PainPhase 3NCT00411268
Safety, Effectiveness, and Impact on Quality of Life on Long-Term Administration of OROS Hydromorphone Slow-Release in Patients With Chronic Low Back Pain
A Phase 3 study testing OROS hydromorphone HCI SR (slow release) in people with Low Back Pain, run by Alza Corporation, DE, USA.
Trial summary
The purpose of this open-label, extension study is to characterize the safety, effectiveness, and impact on quality of life measures of long-term repeated dosing of OROS hydromorphone slow release (8, 16, 32 and 64 mg tablets) in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- OROS hydromorphone HCI SR (slow release)
- How many people
- 207 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jun 2001
- Phase
- Phase 3
- 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
- Patients who have chronic low back pain who have successfully completed short-term Study DO-127 with OROS hydromorphone slow release
- Patients who require at least 8 mg of hydromorphone HCI (slow release) every 24 hours for the management of chronic low back pain
- Patients whose opioid requirements have been stable as demonstrated in short-term Study DO-127 with OROS hydromorphone slow release
Who cannot join
- Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
- Patients who are pregnant or breast-feeding
- Patients with any gastrointestinal disorder, including pre-existing severe GI narrowing (pathologic or iatrogenic) that may affect the absorption or transit of orally administered drugs
- Patients with significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, disorders of cognition, any clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture
- Patients who may be at risk for serious decreases in blood pressure upon taking an opioid analgesic
About this study
Official title: Safety, Efficacy and Impact on Quality of Life of Long-Term Administration of Dilaudid CR (Hydromorphone HCI) in Patients With Chronic Low Back Pain
The purpose of this open-label, extension study is to characterize the safety, effectiveness, and impact on quality of life measures of long-term repeated dosing of OROS hydromorphone slow release (8, 16, 32 and 64 mg tablets) in patients with chronic low back pain.
Read the detailed description
This open label, extension study characterized the safety, effectiveness, and impact on quality of life of OROS hydromorphone slow release with long-term repeated dosing among patients with chronic low back pain, who previously completed short-term Study DO-127 with OROS hydromorphone slow release. Up to 150 patients were to be enrolled and evaluated. Patients were enrolled in this study immediately following Study DO-127. Patients continued their therapy with OROS hydromorphone slow release at the stable dose previously identified in the short-term study. The patient's initial prescribed dose of OROS hydromorphone slow release in Study DO-127X was the same as the last dose of OROS hydromorphone slow release in Study DO-127. Patients returned monthly for evaluations during this extension interval. Adjustments to dose were performed as needed, at the Investigator's discretion. The duration of this study was six months. Safety assessments included vital signs and physical examination at start, during and end of study. 8, 16, 32 and 64 mg tablets of OROS hydromorphone (dose will be at Investigators' discretion) slow release tablets were taken orally daily for the duration of the six month study
- Conditions
- Low Back Pain
- Being tested
- OROS hydromorphone HCI SR (slow release)
- Keywords
- Chronic low back pain, OROS hydromorphone slow release tablet, Quality of Life
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OROS hydromorphone HCI SR (slow release)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The daily pain relief rating obtained during the study.(six months)
Secondary outcomes (1)
Differences from first visit to each subsequent visit in Brief Pain Inventory (BPI) ratings, sleep scores and quality of life questionnaires.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alza Corporation, DE, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alza Corporation Clinical Trial, Study director, ALZA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411268
- Sponsor's protocol ID
- CR013258
- Status last verified
- Apr 2010
- First submitted
- 12 Dec 2006
- Last updated
- 27 Apr 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy and Impact on Quality of Life of Long-Term Administration of Dilaudid CR (Hydromorphone HCI) in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00411268
- Acronym / sponsor ID
- CR013258
- Conditions
- Low Back Pain
- Keywords
- Chronic low back pain, OROS hydromorphone slow release tablet, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Alza Corporation, DE, USAIndustry (pharma, biotech, devices)
- Study completion
- Jun 2001 (actual)
- First posted
- 13 Dec 2006 (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 open-label, extension study is to characterize the safety, effectiveness, and impact on quality of life measures of long-term repeated dosing of OROS hydromorphone slow release (8, 16, 32 and 64 mg tablets) in patients with chronic low back pain.
Detailed description
This open label, extension study characterized the safety, effectiveness, and impact on quality of life of OROS hydromorphone slow release with long-term repeated dosing among patients with chronic low back pain, who previously completed short-term Study DO-127 with OROS hydromorphone slow release. Up to 150 patients were to be enrolled and evaluated. Patients were enrolled in this study immediately following Study DO-127. Patients continued their therapy with OROS hydromorphone slow release at the stable dose previously identified in the short-term study. The patient's initial prescribed dose of OROS hydromorphone slow release in Study DO-127X was the same as the last dose of OROS hydromorphone slow release in Study DO-127. Patients returned monthly for evaluations during this extension interval. Adjustments to dose were performed as needed, at the Investigator's discretion. The duration of this study was six months. Safety assessments included vital signs and physical examination at start, during and end of study. 8, 16, 32 and 64 mg tablets of OROS hydromorphone (dose will be at Investigators' discretion) slow release tablets were taken orally daily for the duration of the six month study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have chronic low back pain who have successfully completed short-term Study DO-127 with OROS hydromorphone slow release
- Patients who require at least 8 mg of hydromorphone HCI (slow release) every 24 hours for the management of chronic low back pain
- Patients whose opioid requirements have been stable as demonstrated in short-term Study DO-127 with OROS hydromorphone slow release
Key exclusion criteria (5 listed)
- Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
- Patients who are pregnant or breast-feeding
- Patients with any gastrointestinal disorder, including pre-existing severe GI narrowing (pathologic or iatrogenic) that may affect the absorption or transit of orally administered drugs
- Patients with significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, disorders of cognition, any clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture
- Patients who may be at risk for serious decreases in blood pressure upon taking an opioid analgesic
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 |
|---|---|---|
| OROS hydromorphone HCI SR (slow release) | Drug | – |
Primary outcome
The daily pain relief rating obtained during the study.(six months)
1 secondary outcome
Differences from first visit to each subsequent visit in Brief Pain Inventory (BPI) ratings, sleep scores and quality of life questionnaires.
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 27 Apr 2010.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Alza Corporation Clinical Trial study director
ALZA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OROS hydromorphone HCI SR (slow release) in people with Low Back Pain, run by Alza Corporation, DE, USA.
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 3 inclusion and 5 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 27 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The daily pain relief rating obtained during the study.(six months). 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 27 Apr 2010.