Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 4

Conditions: Pain

Treatments: Drug: Osmotic Release Oral System (OROS) hydromorphone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01648699

42801PAI4008

CR016351

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorphone using standardized conversion from prior opioid therapy among participants with cancer pain.

Full description

This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than one center) study to evaluate the effectiveness and safety of stable dose of OROS hydromorphone among participants with cancer pain. The duration of this study will be 28 days and will include visits at: Day 0 (Baseline), Day 7, 14 and 28. The OROS hydromorphone will be administered orally for 28 days and 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. Efficacy of the participants will primarily be evaluated by Brief Pain Inventory score. Participants' safety will be monitored throughout the study.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant with histological confirmed malignancy
• Participant on stable morphine or 25 milligram 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
• Participants with signed informed consent

Exclusion criteria

• Participant intolerant or hypersensitive to hydromorphone or other opioid agonist
• Participant with unstable medical condition
• Participant with renal dysfunction and liver dysfunction
• Participant dependence to opiates
• Inability to take oral medication

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Osmotic Release Oral System (OROS) Hydromorphone

Experimental group

Description:

OROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and dose will be increased if needed, but not more than 40 mg and not more frequently than every two days. The study drug will be administered up to 28 days.

Treatment:

Drug: Osmotic Release Oral System (OROS) hydromorphone