An Efficacy and Safety Study of Oral Osmotic Therapeutic System (OROS) Hydromorphone Hydrochloride (HCl) in Participants With Cancer Related Pain

NCT01205126 | Completed Phase 3 Results

• 2 other identifiers: CR01743742801PAI3009
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to compare the safety and efficacy of Oral Osmotic Therapeutic System (OROS) hydromorphone hydrochloride (HCl) with controlled-release oxycodone HCl in participants with cancer-related pain.

Conditions

Pain

Keywords

Pain; Hydromorphone hydrochloride; Oxycodone hydrochloride

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Worst Pain in the Past 24 Hours Assessed by Brief Pain Inventory (BPI) Short Form Questionnaire Score at Day 29

  The BPI is questionnaire for evaluating the degree of pain severity and the impact of pain in performing daily routines. Change in worst pain in the past 24 hours in BPI score was reported. The total score ranges from 0 to 10, wherein 0 indicates no pain and 10 indicates pain as bad as participants could imagine.

  Baseline and Day 29

Secondary Outcomes (5)

• Change From Baseline in Pain at Its Least, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29

  Baseline and Day 29

• Change From Baseline in Average Pain, in the Past 24 Hours Assessed by BPI Short Form Questionnaire Score at Day 29

  Baseline and Day 29

• Change From Baseline in Pain Right Now Assessed by BPI Short Form Questionnaire Score at Day 29

  Baseline and Day 29

• Change From Baseline in Pain Relief, in the Past 24 Hour Recorded Assessed by BPI Short Form Questionnaire at Day 29

  Baseline and Day 29

• Breakthrough Pain Medication (Rescue Medication) Doses Taken

  Baseline up to Day 29

Study Arms (2)

OROS Hydromorphone hydrochloride (HCl)

EXPERIMENTAL

OROS Hydromorphone HCl will be administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titrationphase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioid dose.

Drug: Hydromorphone HCl; Drug: Placebo

Oxycodone HCl Controlled release (CR)

ACTIVE COMPARATOR

Oxycodone HCl will be administered in dose of 10, 20, 30 and 40 mg, twice daily for 2 to 8 days of titrationphase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioids dose.

Drug: Oxycodone HCl CR; Drug: Placebo

Interventions

Hydromorphone HCl DRUG

Hydromorphone HCl will be administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of Titration phase and 28 days of Maintenance phase. Starting dose will be based on participant's previous daily opioid dose.

OROS Hydromorphone hydrochloride (HCl)

Oxycodone HCl CR DRUG

Oxycodone HCl will be administered in dose of 10, 20, 30 and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioids dose.

Oxycodone HCl Controlled release (CR)

Placebo DRUG

Placebo will be administered to the participants receiving hydromorphone HCl or oxycodone HCl CR along with the study treatment to maintain necessary blinding.

OROS Hydromorphone hydrochloride (HCl); Oxycodone HCl Controlled release (CR)

Eligibility Criteria

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

You may qualify if:

• Participants receiving strong oral or transdermal (through the skin) opioid analgesics with inadequate control of moderate to severe (very serious, life threatening) cancer pain or who presented with cancer pain and will be eligible to move to Step 3 of the WHO analgesic ladder when receiving weak opioids
• Participants who require or are expected to require between 40 mg and 184 mg of oral morphine or morphine equivalents every 24 hours for the chronic management of cancer pain
• Participants who are reasonably expected to achieve a stable dose of opioid study medication during the study
• Participants who are not expected to start a course of chemotherapy, radiotherapy, targeted cancer therapy, hormone therapy or diphosphates therapy after enrolment into the study. If participants are receiving long-term treatment including hormone therapy, target cancer therapy and diphosphate, the treatment should be kept stable as much as possible from 2 weeks before randomization and up to the completion of the study, encompassing the titration and maintenance phases
• Female participants who are premenarchal, postmenopausal, or surgically sterile, abstinent or if sexually active, they must use a medically acceptable method of contraception and must be willing to continue to use the same method of contraception throughout the study

You may not qualify if:

• Participants with neuropathic pain or pain of unknown origin, or acute pain - Participants having pain only on movements
• Participants requiring other opioid analgesics (apart from morphine hydrochloride (HCl), in immediate release formulation, allowed as rescue medication for breakthrough pain)
• Participants with a recent history (within the previous 6 months) or current history of drug abuse or alcohol abuse
• Women of childbearing potential who were pregnant or lactating, seeking pregnancy or failing to use an adequate contraceptive method

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (12)

Unknown Facility

Beijing, China

Location

Unknown Facility

Chengdu, China

Location

Unknown Facility

Fuzhou, China

Location

Unknown Facility

Guangdong, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Hefei, China

Location

Unknown Facility

Nanchang, China

Location

Unknown Facility

Nanning, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Tianjin, China

Location

Unknown Facility

Wuhan, China

Location

MeSH Terms

Conditions

Pain

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

Results Point of Contact

• Title: Director, Established Products
• Organization: Janssen Research & Development, LLC

+1 609 730 3387;

Study Officials

• Johnson & Johnson Pharmaceutical Research and Development Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: September 20, 2010
• Study Start: December 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 3, 2014
• Results First Posted: November 25, 2013

Record last verified: 2013-12

Locations

CN (12)