Study of the Effectiveness and Tolerability of OROS Hydromorphone HCI SR(Slow-release) Tablets and Immediate-Release Hydromorphone Tablets in Patients With Chronic Pain

April 26, 2010 updated by: Alza Corporation, DE, USA

A Randomized, Double-Blind, Repeated Dose, Parallel-Group Comparison of the Efficacy & Tolerability of Dilaudid SR Tablets and Immediate Release Dilaudid Tablets (Hydromorphone HCI) in Patients With Chronic Pain

The purpose of this study was to characterize a safe and effective means of conversion and titration to an appropriate dose of hydromorphone HCI, to demonstrate comparable efficacy of OROS hydromorphone HCI SR (slow release) and hydromorphone HCI IR (immediate release) following administration of approximately equivalent total daily doses and demonstrate a significant dose-response relationship between OROS hydromorphone HCI SR (slow release) for breakthrough pain medication use or alternatively, diary-based analgesic scores

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This was a randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), repeated-dose, three-arm parallel group study conducted in three phases. Following a Prior Opioid Stabilization Phase, wherein patients were required to be on a stable dose of chronic opioid therapy, patients were converted, titrated and stabilized on hydromorphone HCI IR (immediate release) to achieve acceptable levels of analgesia in the Open-Label Hydromorphone HCI IR (immediate release) Conversion, Titration, and Stabilization Phase. Supplementary hydromorphone HCI IR (immediate release) was provided for breakthrough pain, and patients were considered stabilized on hydromorphone HCI IR (immediate release) when the total daily dose of hydromorphone HCI IR (immediate release) remained unchanged with no more than three hydromorphone HCI IR (immediate release) breakthrough pain medication doses per day for 2 consecutive days. Patients who were able to achieve a stable total daily dose of at least 20 mg but not more than 60 mg of hydromorphone HCI IR (immediate release) (exclusive of breakthrough pain medication) within the 14 day Open-Label hydromorphone HCI IR (immediate release) Conversion, Titration, and Stabilization Phase of the study entered the Double-Blind, Randomized, Repeat Dosing Phase of the study. Patients were randomized to receive 7 days of either OROS hydromorphone HCI SR (slow release) at a daily dose approximately equal to their stabilized total daily dose of hydromorphone HCI IR (immediate release), OROS hydromorphone HCI SR (slow release) at a daily dose approximately equal to one-half their stabilized total daily dose of hydromorphone HCI IR (immediate release) (1/2 OROS hydromorphone slow release), or hydromorphone HCI IR (immediate release) at the same daily dose on which they were stabilized (hydromorphone immediate release). Patients who completed the study were eligible for participation in an open-label OROS hydromorphone SR (slow release) long-term extension study (Protocol DO-109). OROS hydromorphone slow release 8, 16 and 32 mg tablets, hydromorphone immediate release 2 and 4 mg tablets, placebo immediate release 2 and 4 mg tablets and placebo slow release 8, 16, and 32 mg tablets taken orally for 7 days

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
169

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have chronic non-malignant or cancer pain currently receiving strong or transdermal opioid analgesics on a daily basis or patients suitable for advancement of therapy to step 3 on the WHO (World Health Organization) analgesic ladder
  • Patients who, at Visit 2, require the equivalent of at least 80 mg but no more than 300 mg of oral morphine sulfate (exclusive of breakthrough pain medication) every 24 hours or at least 25 micrograms an hour but no more than 75 micrograms an hour of Fentanyl
  • Patients must be on a stable dose of a strong opioid medication at Visit 2. Patients will be considered stabilized when the total daily dose of their prestudy opioid medication remains unchanged, with no more than three opioid breakthrough pain doses/day administered for breakthrough pain, for two consecutive days
  • Patients who can be expected to have reasonably stable opioid requirements for the duration of the study

Exclusion Criteria:

  • Patients intolerant of or hypersensitive to hydromorphone (or other opioid agonists)
  • Patients who have difficulty swallowing or are unable to swallow tablets
  • Patients who are pregnant or breast-feeding. Female patients of child-bearing potential must be following a medically recognized contraceptive program prior to and during the study. A negative pregnancy test is required prior to administration of study drug
  • Patients with any gastrointestinal disorder, including pre-existing severe gastrointestinal narrowing that may affect the absorption or transit of orally administered drugs
  • Patients with any intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorders of cognition
  • Patients with clinically significant impaired kidney or liver function, thyroid disease, enlarged prostate, or urethral narrowing
  • Patients who may be at risk for serious decreases in blood pressure upon administration of an opioid analgesic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
This study demonstrated a dose-response relationship with OROS hydromorphone slow release and no statistically significant differences in efficacy results between OROS hydromorphone slow release and immediate release at approximately equal doses.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
There were no statistically significant differences between treatment groups in measures of efficacy at baseline or endpoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alza Corporation, DE, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 1999

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR013276

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