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OROS hydromorphone HCL ; Morphine sulfate

Alza Corporation Clinical Trial

The purpose of this study was to demonstrate the clinical equivalence of hydromorphone and morphine (immediate-release \[IR\] and sustained-release \[SR\] formulations) using the "worst pain in the past 24 hours" item of the Brief Pain Inventory (BPI). The secondary objective of this study was to compare hydromorphone and morphine in the following variables: other pain measures, various questionnaires, and safety and tolerability variables.

This was a phase-3, multicenter, multinational, randomized (patients are assigned different treatments based on chance), active-controlled, double-blind, multiple-ascending-dose, parallel-group study in adult patients with cancer pain who receive and/or require strong oral or transdermal opioid analgesics (60-540 mg of oral morphine equivalents daily). This study consisted of 2 phases: an initial immediate release (IR) phase and a subsequent slow release (SR) phase. Eligible patients were randomized 1:1 to receive either OROS hydromorphone HCl or morphine sulfate (immediate release formulation in the immediate release phase, slow release formulation in the slow release phase). In the immediate release phase (2-9 days), patients were started on the appropriate initial dose of immediate release medication every 4 hours (q4h), (6 doses/day) using a 5:1 conversion ratio (morphine equivalents:hydromorphone dosage). If the patient had greater than 3 breakthrough-pain episodes requiring additional pain medication in 24 hours, the study medication dosage was increased, at most once a day. When the patient had achieved dose-stable pain control (2 days with 3 or less than 3 breakthrough-pain episodes per day), the patient was permitted to continue into the slow release phase. The patient was given an equivalent dosage of a slow release formulation of the same drug (OROS® hydromorphone HCL each day or morphine sulfate slow release two times per day), administered using a double-dummy technique. Dosage increases were permitted every 2 days if the patient had more than 3 breakthrough-pain episodes in 24 hours. To complete the slow release phase, patients had to achieve dose-stable pain control for at least 2 days.Safety assessments of physical examination, labs and adverse event reporting were done. OROS hydromorphone HCL slow release 8, 16, 32, and 64mg tablets; Morphine sulfate immediate release10, 20, 50 mg capsules;Morphine sulfate slow release 5, 30, 60, 90, 120, 160, and 200mg capsules;hydromorphone immediate release 2, 4, 8 mg;The immediate release medications orally every 4 hours;The OROS hydromorphone slow release formulation orally every 24 hours and morphine slow release orally twice daily.

A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.

A Randomized, Double-Blind, Controlled Trial of Hydromorphone (Immediate and Sustained- Release) vs Morphine (Immediate and Sustained-release) in Cancer Pain

Alza Corporation, DE, USA

Rare Diseases

Chronic Pain

Chronic Graft Versus Host Disease

OROS Hydromorphone HCI SR (slow release)

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

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

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

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.	NCT00410540	Pain Analgesics, Opi...	OROS hydromorph...	18 Years -	Alza Corporation, DE, USA
A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.	NCT00410540	Pain Analgesics, Opi...	OROS hydromorph...	18 Years -	Alza Corporation, DE, USA
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	Pain	OROS Hydromorph...	18 Years -	Alza Corporation, DE, USA
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	Pain	OROS Hydromorph...	18 Years -	Alza Corporation, DE, USA
A Study of OROS Hydromorphone HCL vs Morphine in Cancer Pain Patients.	NCT00410540	Pain Analgesics, Opi...	OROS hydromorph...	18 Years -	Alza Corporation, DE, USA

Spots Global Cancer Trial Database for oral analgesic