Study of the Effectiveness and Tolerability of OROS Hydromorphone HCI SR(Slow-release) Tablets and Immediate-Release Hydromorphone Tablets in Patients With Chronic Pain

NCT00410943 | Completed Phase 3

• 1 other identifier: CR013276
• Study Type: interventional
• Target: 169
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pain

Keywords

Cancer pain; Oral analgesic; OROS hydromorphone HCI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• There were no statistically significant differences between treatment groups in measures of efficacy at baseline or endpoint

Interventions

OROS Hydromorphone HCI SR (slow release) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alza Corporation, DE, USA: lead

MeSH Terms

Conditions

Pain; Cancer Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alza Corporation Clinical Trial

  ALZA

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 12, 2006
• First Posted: December 13, 2006
• Study Completion: June 1, 1999
• Last Updated: April 27, 2010

Record last verified: 2010-04