An Efficacy and Safety Study of Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS) in the Reduction of Breakthrough Pain Medication Frequency in Participants With Cancer

NCT01006356 | Completed Phase 4 Results

• 2 other identifiers: CR01569442801PAI4006
• Study Type: interventional
• Target: 141
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the clinical efficacy of hydromorphone hydrochloride (HCl) Oral Osmotic System (OROS) by assessing the extent of reduction of medication frequency for the management of breakthrough pain after the administration of hydromorphone HCl OROS in Korean cancer participants.

Conditions

Cancer; Pain

Keywords

Hydromorphone hydrochloride Oral Osmotic System; Jurnista

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain

  Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started).

  Day 15

Secondary Outcomes (8)

• Frequency of Experiencing Breakthrough Pain

  Day 1 and Day 15

• Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15

  Baseline and Day 15

• Pain Intensity Score

  Day 3 and Day 13

• Global Assessment of Overall Efficacy of Study Drug by Investigator

  Day 15

• Global Assessment of Overall Efficacy of Study Drug by Participant

  Day 15

Study Arms (1)

Hydromorphone hydrochloride (HCl) oral osmotic system (OROS)

EXPERIMENTAL

Hydromorphone HCl OROS 8 milligram (mg) once daily for 2 weeks.

Drug: Hydromorphone HCl OROS

Interventions

Hydromorphone HCl OROS DRUG

Hydromorphone HCl OROS 8 mg once daily for 2 weeks.

Hydromorphone hydrochloride (HCl) oral osmotic system (OROS)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer participants administering only strong oral opioid analgesic for cancer pain control
• Participants administering short-acting narcotic analgesics at least twice daily due to breakthrough pain for 3 days just before Visit 2 (Day 1)
• Participants sufficiently capable of complying overall study requirements including participant diary for pain at the discretion of the Investigators
• Abstinent or surgically sterile female participants

You may not qualify if:

• Participants with cancer pain who are potentially unresponsive to narcotic analgesics
• Participants with presence or history of drug or alcohol abuse within the past 6 months
• Participants with hypersensitivity to hydromorphone HCl
• Participants with history of colectomy (surgery to remove part or all of the colon)
• Participants with severe digestive tract disease which might interfere with oral analgesic effects, such as dysphagia (trouble swallowing), vomiting, no bowel movement, ileus, and severe enterostenosis that can influence absorption and passing through of oral medication

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

MeSH Terms

Conditions

Neoplasms; Pain

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Director
• Organization: Medical department / Korea

+82-2-2094-4518

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  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: October 29, 2009
• First Posted: November 2, 2009
• Study Start: October 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 8, 2013
• Results First Posted: August 8, 2013

Record last verified: 2013-07