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


Phase 4
18 Years
70 Years
Not Enrolling
Both
Pain

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in Brief Pain Inventory (BPI) Average Score from Baseline

Outcome Description:

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).

Outcome Time Frame:

Baseline and 28 days

Safety Issue:

No

Principal Investigator

Janssen Pharmaceutica Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Pharmaceutica

Authority:

Philippines: Bureau of Food and Drugs

Study ID:

CR016351

NCT ID:

NCT01648699

Start Date:

October 2009

Completion Date:

September 2010

Related Keywords:

  • Pain
  • Pain
  • Cancer pain
  • OROS hydromorphone
  • Jurnista

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