Study on the Effectiveness and Safety of Oros Hydromorphone in Pain Management Among Patients With Cancer Pain - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: OROS hydromorphone 4 mg	Phase 4

Study Type:	Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Hydromorphone hydrochloride Hydromorphone

U.S. FDA Resources

Further study details as provided by Janssen Pharmaceutica:

Primary Outcome Measures:

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).

Secondary Outcome Measures:

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 ]

Enrollment:	20
Study Start Date:	October 2009
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient with histological confirmed malignancy
Patient on stable 50 mg dose morphine or 25 mg oxycodone dose equivalent per day. Stable dose is defined as no dose change for 3 consecutive days and does not require more than 3 doses of rescue medication per day
Life expectancy of at least 3 months
Negative urine pregnancy test
Patients with signed informed consent

Exclusion Criteria:

Patient intolerant or hypersensitive to hydromorphone or other opioid agonist
Patient with unstable medical condition
Renal dysfunction
Liver dysfunction
Patient dependence to opiates
Inability to take oral medication
History of surgical procedures and/or underlying disease that would result in the narrowing of the gastrointestinal tract, or have blind loops of the tract or obstruction
Patient taking monoamine oxidase inhibitors (MAOls) for the past 14 days prior to screening
Patient with status asthmaticus
Patient with chronic obstructive pulmonary disease (COPD) history
Patient with hydromorphone therapy history
Pregnant or breast feeding
Patient participating in a trial 30 days prior to screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648699

Locations

Philippines

Cebuu City, Philippines

Davao City, Philippines

Manila, Philippines

Pasig National Capitol Region, Philippines

Quezon City, Philippines

Sponsors and Collaborators

Janssen Pharmaceutica

Investigators

Study Director:

Janssen Pharmaceutica Clinical Trial

Janssen Pharmaceutica

More Information

No publications provided

Responsible Party:	Janssen Pharmaceutica
ClinicalTrials.gov Identifier:	NCT01648699 History of Changes
Other Study ID Numbers:	CR016351, 42801PAI4008
Study First Received:	July 20, 2012
Last Updated:	August 10, 2012
Health Authority:	Philippines: Bureau of Food and Drugs

Keywords provided by Janssen Pharmaceutica:

Pain
Cancer pain
OROS hydromorphone
Jurnista

Additional relevant MeSH terms:

Hydromorphone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on June 18, 2013