Analgesics, OpioidPhase 3NCT00411034
A Repeated-Dose Evaluation of Use of a Pain Relieving Drug and Safety of OROS Hydromorphone HCI in Patients With Chronic Cancer Pain
A Phase 3 study testing OROS Hydromorphone HCI in people with Analgesics, Opioid and Pain, 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 HCI (slow release) in patients with chronic cancer 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
- Analgesics, Opioid, Pain
- What is being tested?
- OROS Hydromorphone HCI
- How many people
- 463 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Sep 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 cancer pain who are currently receiving strong oral or transdermal opioid analgesics or patients suitable for advancement of therapy to step 3 on the WHO (World Health Organization) analgesic ladder
- 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 are pregnant or breast-feeding
- patients with severe respiratory compromise or severely depressed ventilatory function
- patients with any gastrointestinal disorder or acute abdominal conditions including pre-existing severe GI narrowing (pathologic or iatrogenic), that may affect the absorption or transit of orally administered drugs
- patients with clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture, dysphagia or are unable to swallow tablets or 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 Cancer Pain
The purpose of this repeated dose study is to develop recommended dosing information for initiation of therapy with OROS Hydromorphone HCI (slow release) in patients with chronic cancer 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 (slow release). The safety profile for OROS Hydromorphone HCI (slow release) will also be evaluated.
Read the detailed description
This randomized (patients assigned to treatment by chance), single-blind (with respect to dose), open-label (patients know what study treatment, not dose, they are receiving) repeated dose study evaluating patients with chronic cancer pain was conducted in tandem (together) with a similar protocol in patients with chronic non-malignant 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 (slow release) using oral morphine equivalents. Supplementary immediate-release (IR) hydromorphone was provided for breakthrough pain. The dose of OROS hydromorphone (slow release) 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 (slow release) 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 (slow release) 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 (slow release) at Visit 2,3, and 4 (either 8,16,32, and/or 64mg tablets) taken orally. OROS Hydromorphone HCI (slow release) doses were titrated after every two days of therapy as necessary until dose stabilization occured, followed by a two week Maintenance Therapy Phase.
- Conditions
- Analgesics, Opioid, Pain
- Being tested
- OROS Hydromorphone HCI
- Keywords
- Opioids, Chronic Cancer Pain, analgesic
- 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 completionSep 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesics, OpioidStudies 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
- 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
- NCT00411034
- Sponsor's protocol ID
- CR011614
- 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
- A Repeated-Dose Evaluation of Analgesic Use and Safety of Dilaudid SR( Hydromorphone HCI) in Patients With Chronic Cancer Pain
- ClinicalTrials.gov ID
- NCT00411034
- Acronym / sponsor ID
- CR011614
- Conditions
- Analgesics, Opioid, Pain
- Keywords
- Opioids, Chronic Cancer Pain, analgesic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- Alza Corporation, DE, USAIndustry (pharma, biotech, devices)
- Study completion
- Sep 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 HCI (slow release) in patients with chronic cancer 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 (slow release). The safety profile for OROS Hydromorphone HCI (slow release) will also be evaluated.
Detailed description
This randomized (patients assigned to treatment by chance), single-blind (with respect to dose), open-label (patients know what study treatment, not dose, they are receiving) repeated dose study evaluating patients with chronic cancer pain was conducted in tandem (together) with a similar protocol in patients with chronic non-malignant 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 (slow release) using oral morphine equivalents. Supplementary immediate-release (IR) hydromorphone was provided for breakthrough pain. The dose of OROS hydromorphone (slow release) 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 (slow release) 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 (slow release) 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 (slow release) at Visit 2,3, and 4 (either 8,16,32, and/or 64mg tablets) taken orally. OROS Hydromorphone HCI (slow release) doses were titrated after every two days of therapy as necessary until dose stabilization occured, followed by a two week Maintenance Therapy Phase.
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 (2 listed)
- Patients who have chronic cancer pain who are currently receiving strong oral or transdermal opioid analgesics or patients suitable for advancement of therapy to step 3 on the WHO (World Health Organization) analgesic ladder
- patients who can reasonably be expected to have stable opioid requirements for the duration of the study
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 severe respiratory compromise or severely depressed ventilatory function
- patients with any gastrointestinal disorder or acute abdominal conditions including pre-existing severe GI narrowing (pathologic or iatrogenic), that may affect the absorption or transit of orally administered drugs
- patients with clinically significant impaired renal or hepatic function, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture, dysphagia or are unable to swallow tablets or 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
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.
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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 Analgesics, Opioid and 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 2 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?
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?
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.