PainPhase 3NCT00410644
A Repeated-Dose Evaluation of a Pain Relieving Drug Use and Safety of OROS Hydromorphone HCI in Patients With Chronic Non-Malignant Pain
A Phase 3 study testing OROS Hydromorphone HCI in people with Pain and Analgesics, run by Alza Corporation, DE, USA.
Trial summary
The purpose of this repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone in patients with chronic non-malignant pain converting from other strong oral or transdermal opioids. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Analgesics, Opioid
- What is being tested?
- OROS Hydromorphone HCI
- How many people
- 463 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Feb 1999
- 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 non-malignant pain, including pain associated with AIDS, who are currently receiving strong oral or transdermal opioid analgesics, or patients who are currently receiving opioids plus non-opioid combination analgesics, and have persisting pain
- patients who require at least 45 mg of oral morphine or opioid equivalent every 24 hours for the management of chronic non-malignant pain
- patients who can reasonably be expected to have stable opioid requirements for the duration of the study.
Who cannot join
- Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
- patients who have dysphagia or are unable to swallow tablets
- patients who are pregnant or breast-feeding
- patients with severe respiratory compromise or severely depressed ventilatory function
- 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 or have an acute abdominal condition that may be obscured by opioids
- patients with clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture
- patients who are known active drug abusers or alcoholics
- patients with any significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorders of cognition
About this study
Official title: A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR (Hydromorphone HCI) in Patients With Chronic Non-Malignant Pain
The purpose of this repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone in patients with chronic non-malignant pain converting from other strong oral or transdermal opioids. It will also assist in the development of a recommended starting dose by which patients can be titrated to an appropriate maintenance dose of OROS Hydromorphone HCI. The safety profile for OROS Hydromorphone HCI will also be evaluated.
Read the detailed description
This single-blind (with respect to dose), repeated dose study evaluating patients with chronic non-malignant pain was conducted in tandem with a similar protocol in patients with chronic cancer pain. A total of 463 patients were enrolled and evaluated in these studies. Patients receiving chronic opioid therapy were converted to once daily OROS hydromorphone using oral morphine equivalents. Supplementary immediate-release (IR) hydromorphone was provided for breakthrough pain. The dose of OROS hydromorphone was escalated after every 2 days of therapy until no more than 3 doses of immediate-release(IR) hydromorphone were required in a 24-hour period. Once a patient could be maintained on a stable dose of OROS hydromorphone for 3 consecutive days, the patient entered a 2-week maintenance phase. Patients who completed the study were eligible for participation in an OROS hydromorphone long-term extension study, Study DO-109. The hypothesis is the 24-hour controlled-release form of oral hydromorphone may provide consistent pain relief, convenient dosing, and enhanced compliance while possibly decreasing the incidence of side effects associated with peak (high) and trough (low) fluctuations in plasma drug concentrations typically seen with immediate-release dosage formulations. Patients received OROS Hydromorphone HCI at Visit 2,3, and 4(either 8,16,32, and/or 64mg tablets) taken orally. OROS Hydromorphone HCI doses were titrated after every two days of therapy as necessary until dose stabilization occurred, followed by a two week Maintenance Therapy Phase.
- Conditions
- Pain, Analgesics, Opioid
- Being tested
- OROS Hydromorphone HCI
- Keywords
- Non-malignant chronic pain, pain, analgesics, opioid
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OROS Hydromorphone HCIDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
No primary efficacy variable was defined in report. Protocol variables measured included: Total daily dose of OROS hydromorphone, daily use of rescue medication, daily pain relief scores, and time/number of steps needed for dose stabilization.
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 completionFeb 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 463 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
- NCT00410644
- Sponsor's protocol ID
- CR011617
- Status last verified
- Apr 2010
- First submitted
- 12 Dec 2006
- Last updated
- 27 Apr 2010
- Results posted
- No
Publications
Wallace M, Rauck RL, Moulin D, Thipphawong J, Khanna S, Tudor IC. Conversion from standard opioid therapy to once-daily oral extended-release hydromorphone in patients with chronic cancer pain. J Int Med Res. 2008 Mar-Apr;36(2):343-52. doi: 10.1177/147323000803600218.
PubMed 18380946Wallace M, Rauck RL, Moulin D, Thipphawong J, Khanna S, Tudor IC. Once-daily OROS hydromorphone for the management of chronic nonmalignant pain: a dose-conversion and titration study. Int J Clin Pract. 2007 Oct;61(10):1671-6. doi: 10.1111/j.1742-1241.2007.01500.x.
PubMed 17877652
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
- A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR (Hydromorphone HCI) in Patients With Chronic Non-Malignant Pain
- ClinicalTrials.gov ID
- NCT00410644
- Acronym / sponsor ID
- CR011617
- Conditions
- Pain, Analgesics, Opioid
- Keywords
- Non-malignant chronic pain, pain, analgesics, opioid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Alza Corporation, DE, USAIndustry (pharma, biotech, devices)
- Study completion
- Feb 1999 (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 repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone in patients with chronic non-malignant pain converting from other strong oral or transdermal opioids. It will also assist in the development of a recommended starting dose by which patients can be titrated to an appropriate maintenance dose of OROS Hydromorphone HCI. The safety profile for OROS Hydromorphone HCI will also be evaluated.
Detailed description
This single-blind (with respect to dose), repeated dose study evaluating patients with chronic non-malignant pain was conducted in tandem with a similar protocol in patients with chronic cancer pain. A total of 463 patients were enrolled and evaluated in these studies. Patients receiving chronic opioid therapy were converted to once daily OROS hydromorphone using oral morphine equivalents. Supplementary immediate-release (IR) hydromorphone was provided for breakthrough pain. The dose of OROS hydromorphone was escalated after every 2 days of therapy until no more than 3 doses of immediate-release(IR) hydromorphone were required in a 24-hour period. Once a patient could be maintained on a stable dose of OROS hydromorphone for 3 consecutive days, the patient entered a 2-week maintenance phase. Patients who completed the study were eligible for participation in an OROS hydromorphone long-term extension study, Study DO-109. The hypothesis is the 24-hour controlled-release form of oral hydromorphone may provide consistent pain relief, convenient dosing, and enhanced compliance while possibly decreasing the incidence of side effects associated with peak (high) and trough (low) fluctuations in plasma drug concentrations typically seen with immediate-release dosage formulations. Patients received OROS Hydromorphone HCI at Visit 2,3, and 4(either 8,16,32, and/or 64mg tablets) taken orally. OROS Hydromorphone HCI doses were titrated after every two days of therapy as necessary until dose stabilization occurred, followed by a two week Maintenance Therapy Phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
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 non-malignant pain, including pain associated with AIDS, who are currently receiving strong oral or transdermal opioid analgesics, or patients who are currently receiving opioids plus non-opioid combination analgesics, and have persisting pain
- patients who require at least 45 mg of oral morphine or opioid equivalent every 24 hours for the management of chronic non-malignant pain
- patients who can reasonably be expected to have stable opioid requirements for the duration of the study.
Key exclusion criteria (8 listed)
- Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
- patients who have dysphagia or are unable to swallow tablets
- patients who are pregnant or breast-feeding
- patients with severe respiratory compromise or severely depressed ventilatory function
- 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 or have an acute abdominal condition that may be obscured by opioids
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 | Drug | – |
Primary outcome
No primary efficacy variable was defined in report. Protocol variables measured included: Total daily dose of OROS hydromorphone, daily use of rescue medication, daily pain relief scores, and time/number of steps needed for dose stabilization.
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.
- Derived from this study: PubMed 18380946Wallace M, Rauck RL, Moulin D, Thipphawong J, Khanna S, Tudor IC. Conversion from standard opioid therapy to once-daily oral extended-release hydromorphone in patients with chronic cancer pain. J Int Med Res. 2008 Mar-Apr;36(2):343-52. doi: 10.1177/147323000803600218.
- Derived from this study: PubMed 17877652Wallace M, Rauck RL, Moulin D, Thipphawong J, Khanna S, Tudor IC. Once-daily OROS hydromorphone for the management of chronic nonmalignant pain: a dose-conversion and titration study. Int J Clin Pract. 2007 Oct;61(10):1671-6. doi: 10.1111/j.1742-1241.2007.01500.x.
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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.
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 in people with Pain and Analgesics, 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 8 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?
No primary efficacy variable was defined in report. Protocol variables measured included: Total daily dose of OROS hydromorphone, daily use of rescue medication, daily pain relief scores, and time/number of steps needed for dose stabilization.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00410644, which also lists 2 linked publications.
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.