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
18 Years
N/A
Both
Pain
Trial Information
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
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
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.
Principal Investigator
Alza Corporation Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
ALZA
Authority:
United States: Institutional Review Board
Study ID:
CR013276
NCT ID:
NCT00410943
Start Date:
Completion Date:
June 1999
Related Keywords:
- Pain
- Cancer pain
- Oral analgesic
- OROS hydromorphone HCI
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