Study of the Effectiveness and Tolerability of OROS Hydromorphone HCI SR(Slow-release) Tablets and Immediate-Release Hydromorphone Tablets in Patients With Chronic Pain
Primary Purpose
Pain
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
OROS Hydromorphone HCI SR (slow release)
Sponsored by
About this trial
This is an interventional treatment trial for Pain focused on measuring Cancer pain, Oral analgesic, OROS hydromorphone HCI
Eligibility Criteria
Inclusion Criteria:
- Patients who have chronic non-malignant or cancer pain currently receiving strong or transdermal opioid analgesics on a daily basis or patients suitable for advancement of therapy to step 3 on the WHO (World Health Organization) analgesic ladder
- Patients who, at Visit 2, require the equivalent of at least 80 mg but no more than 300 mg of oral morphine sulfate (exclusive of breakthrough pain medication) every 24 hours or at least 25 micrograms an hour but no more than 75 micrograms an hour of Fentanyl
- Patients must be on a stable dose of a strong opioid medication at Visit 2. Patients will be considered stabilized when the total daily dose of their prestudy opioid medication remains unchanged, with no more than three opioid breakthrough pain doses/day administered for breakthrough pain, for two consecutive days
- Patients who can be expected to have reasonably stable opioid requirements for the duration of the study
Exclusion Criteria:
- Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
- Patients who have difficulty swallowing or are unable to swallow tablets
- Patients who are pregnant or breast-feeding. Female patients of child-bearing potential must be following a medically recognized contraceptive program prior to and during the study. A negative pregnancy test is required prior to administration of study drug
- Patients with any gastrointestinal disorder, including pre-existing severe gastrointestinal narrowing that may affect the absorption or transit of orally administered drugs
- Patients with any intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorders of cognition
- Patients with clinically significant impaired kidney or liver function, thyroid disease, enlarged prostate, or urethral narrowing
- Patients who may be at risk for serious decreases in blood pressure upon administration of an opioid analgesic
Sites / Locations
Outcomes
Primary Outcome Measures
This study demonstrated a dose-response relationship with OROS hydromorphone slow release and no statistically significant differences in efficacy results between OROS hydromorphone slow release and immediate release at approximately equal doses.
Secondary Outcome Measures
There were no statistically significant differences between treatment groups in measures of efficacy at baseline or endpoint
Full Information
NCT ID
NCT00410943
First Posted
December 12, 2006
Last Updated
April 26, 2010
Sponsor
Alza Corporation, DE, USA
1. Study Identification
Unique Protocol Identification Number
NCT00410943
Brief Title
Study of the Effectiveness and Tolerability of OROS Hydromorphone HCI SR(Slow-release) Tablets and Immediate-Release Hydromorphone Tablets in Patients With Chronic Pain
Official Title
A Randomized, Double-Blind, Repeated Dose, Parallel-Group Comparison of the Efficacy & Tolerability of Dilaudid SR Tablets and Immediate Release Dilaudid Tablets (Hydromorphone HCI) in Patients With Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
June 1999 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Alza Corporation, DE, USA
4. Oversight
5. Study Description
Brief Summary
The purpose of this study was to characterize a safe and effective means of conversion and titration to an appropriate dose of hydromorphone HCI, to demonstrate comparable efficacy of OROS hydromorphone HCI SR (slow release) and hydromorphone HCI IR (immediate release) following administration of approximately equivalent total daily doses and demonstrate a significant dose-response relationship between OROS hydromorphone HCI SR (slow release) for breakthrough pain medication use or alternatively, diary-based analgesic scores
Detailed Description
This was a randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), repeated-dose, three-arm parallel group study conducted in three phases. Following a Prior Opioid Stabilization Phase, wherein patients were required to be on a stable dose of chronic opioid therapy, patients were converted, titrated and stabilized on hydromorphone HCI IR (immediate release) to achieve acceptable levels of analgesia in the Open-Label Hydromorphone HCI IR (immediate release) Conversion, Titration, and Stabilization Phase. Supplementary hydromorphone HCI IR (immediate release) was provided for breakthrough pain, and patients were considered stabilized on hydromorphone HCI IR (immediate release) when the total daily dose of hydromorphone HCI IR (immediate release) remained unchanged with no more than three hydromorphone HCI IR (immediate release) breakthrough pain medication doses per day for 2 consecutive days. Patients who were able to achieve a stable total daily dose of at least 20 mg but not more than 60 mg of hydromorphone HCI IR (immediate release) (exclusive of breakthrough pain medication) within the 14 day Open-Label hydromorphone HCI IR (immediate release) Conversion, Titration, and Stabilization Phase of the study entered the Double-Blind, Randomized, Repeat Dosing Phase of the study. Patients were randomized to receive 7 days of either OROS hydromorphone HCI SR (slow release) at a daily dose approximately equal to their stabilized total daily dose of hydromorphone HCI IR (immediate release), OROS hydromorphone HCI SR (slow release) at a daily dose approximately equal to one-half their stabilized total daily dose of hydromorphone HCI IR (immediate release) (1/2 OROS hydromorphone slow release), or hydromorphone HCI IR (immediate release) at the same daily dose on which they were stabilized (hydromorphone immediate release). Patients who completed the study were eligible for participation in an open-label OROS hydromorphone SR (slow release) long-term extension study (Protocol DO-109). OROS hydromorphone slow release 8, 16 and 32 mg tablets, hydromorphone immediate release 2 and 4 mg tablets, placebo immediate release 2 and 4 mg tablets and placebo slow release 8, 16, and 32 mg tablets taken orally for 7 days
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Cancer pain, Oral analgesic, OROS hydromorphone HCI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
OROS Hydromorphone HCI SR (slow release)
Primary Outcome Measure Information:
Title
This study demonstrated a dose-response relationship with OROS hydromorphone slow release and no statistically significant differences in efficacy results between OROS hydromorphone slow release and immediate release at approximately equal doses.
Secondary Outcome Measure Information:
Title
There were no statistically significant differences between treatment groups in measures of efficacy at baseline or endpoint
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have chronic non-malignant or cancer pain currently receiving strong or transdermal opioid analgesics on a daily basis or patients suitable for advancement of therapy to step 3 on the WHO (World Health Organization) analgesic ladder
Patients who, at Visit 2, require the equivalent of at least 80 mg but no more than 300 mg of oral morphine sulfate (exclusive of breakthrough pain medication) every 24 hours or at least 25 micrograms an hour but no more than 75 micrograms an hour of Fentanyl
Patients must be on a stable dose of a strong opioid medication at Visit 2. Patients will be considered stabilized when the total daily dose of their prestudy opioid medication remains unchanged, with no more than three opioid breakthrough pain doses/day administered for breakthrough pain, for two consecutive days
Patients who can be expected to have reasonably stable opioid requirements for the duration of the study
Exclusion Criteria:
Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
Patients who have difficulty swallowing or are unable to swallow tablets
Patients who are pregnant or breast-feeding. Female patients of child-bearing potential must be following a medically recognized contraceptive program prior to and during the study. A negative pregnancy test is required prior to administration of study drug
Patients with any gastrointestinal disorder, including pre-existing severe gastrointestinal narrowing that may affect the absorption or transit of orally administered drugs
Patients with any intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorders of cognition
Patients with clinically significant impaired kidney or liver function, thyroid disease, enlarged prostate, or urethral narrowing
Patients who may be at risk for serious decreases in blood pressure upon administration of an opioid analgesic
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alza Corporation Clinical Trial
Organizational Affiliation
ALZA
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Study of the Effectiveness and Tolerability of OROS Hydromorphone HCI SR(Slow-release) Tablets and Immediate-Release Hydromorphone Tablets in Patients With Chronic Pain
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