A Repeated-Dose Evaluation of a Pain Relieving Drug Use and Safety of OROS Hydromorphone HCI in Patients With Chronic Non-Malignant Pain

NCT00410644 | Completed Phase 3

• 1 other identifier: CR011617
• Study Type: interventional
• Target: 463
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Pain; Analgesics; Opioid

Keywords

Non-malignant chronic pain; pain; analgesics; opioid

Outcome Measures

Primary Outcomes (1)

• 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.

Interventions

OROS Hydromorphone HCI 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Alza Corporation, DE, USA: lead

Related Publications (2)

• 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.

  PMID: 18380946 DERIVED

• Wallace 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.

  PMID: 17877652 DERIVED

MeSH Terms

Conditions

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: NON RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

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

Record last verified: 2010-04