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

NCT01648699 | Terminated Phase 4 Results

• 2 other identifiers: CR01635142801PAI4008
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain

Keywords

Pain; Cancer; Osmotic Release Oral System; OROS Hydromorphone; Jurnista

Outcome Measures

Primary Outcomes (2)

• Brief Pain Inventory (BPI) Average Score at Baseline

  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.

  Baseline

• Brief Pain Inventory (BPI) Average Score at Day 28

  The 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.

  Day 28

Secondary Outcomes (2)

• Number of Participants Given Rescue Pain Medications

  Day 28

• Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician

  Day 28

Study Arms (1)

Osmotic Release Oral System (OROS) Hydromorphone

EXPERIMENTAL

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.

Drug: Osmotic Release Oral System (OROS) hydromorphone

Interventions

Osmotic Release Oral System (OROS) hydromorphone DRUG

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.

Also known as: Jumista

Osmotic Release Oral System (OROS) Hydromorphone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutica: lead

MeSH Terms

Conditions

Pain; Neoplasms

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Limitations and Caveats

The study was prematurely terminated due to administrative reason.

Results Point of Contact

• Title: Medical Affairs Manager
• Organization: Janssen Philippines

+632-8248935

Study Officials

• Janssen Pharmaceutica Clinical Trial

  Janssen Pharmaceutica

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2012
• First Posted: July 24, 2012
• Study Start: April 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 11, 2013
• Results First Posted: October 11, 2013

Record last verified: 2013-10