Study on the Effectiveness and Safety of Oros Hydromorphone in Pain Management Among Patients With Cancer Pain
The purpose of this study is to evaluate the effectiveness and safety of OROS hydromorphone using standardized conversion from prior opioid therapy among patients with cancer pain.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Study on the Effectiveness and Safety of Oros Hydromorphone in Pain Management Among Patients With Cancer Pain|
- Change in Brief Pain Inventory (BPI) Average Score from Baseline [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]The Brief Pain Inventory (BPI) assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0 (=no pain) and 10 (=pain as bad as you can imagine). The interference items are scored from 0 (=no interference) and 10 (=interferes completely).
- Number of Patients Given Rescue Pain Medications [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Change in Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline and 28 days ] [ Designated as safety issue: No ]The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of change per visit, from "very much worse" to "very much improved".
- Incidence of Adverse Events [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Incidence of discontinuation due to Adverse Events [ Time Frame: 28 days ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
|Experimental: OROS hydromorphone||
Drug: OROS hydromorphone 4 mg
Type= range, unit= mg, number= 8 to 40, form= tablet, route= oral use. One single daily dose of OROS hydromorphone, determined according to the conversion of the daily dose of opioid use. The dose can be gradually increased if the pain increases in severity or analgesia was inadequate.
This is a prospective, open label (all people know the identity of the intervention), single-arm, multicenter study to evaluate the effectiveness and safety of a standardized conversion from prior opioid therapy to a stable dose of OROS hydromorphone among patients with cancer pain. Participants will be patients with cancer pain who are on stable dose of morphine or oxycodone. Patients will be followed-up until Day 28. Dose titration (incremental increase in drug dosage to a level that provides the optimal therapeutic effect) will be done every two days upon administration of dose. Rescue medication (a medication intended to relieve symptoms immediately) of morphine will be permitted throughout the study duration. The primary indicator used for effectiveness will be Brief Pain Inventory (BPi) scores. The safety indicator will be incidence of adverse events (AEs) and incidence of discontinuation due to AE.
|Cebuu City, Philippines|
|Davao City, Philippines|
|Pasig National Capitol Region, Philippines|
|Quezon City, Philippines|
|Study Director:||Janssen Pharmaceutica Clinical Trial||Janssen Pharmaceutica|