A Repeated Dose Study of the Metabolism and Action Evaluation of OROS Hydromorphone HCI (Slow Release) Tablets in Patients With Chronic Pain

February 15, 2017 updated by: Alza Corporation, DE, USA

A Repeated-Dose Pharmacokinetic Evaluation of Dilaudid SR Tablets (Hydromorphone HCI) in Patients With Chronic Pain

The purpose of this study was to characterize the steady-state pharmacokinetic (metabolism and action) profile of OROS hydromorphone HCI (slow release) in patients who required opioid therapy on a daily basis for chronic pain conditions. Patients stabilized on prior opioids were converted to OROS hydromorphone slow release and titrated (slowly increased or decreased) to adequate analgesia (pain relief). They were maintained at that dose for 4-10 days and had blood samples drawn over 24 hours on the last day of study.

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 an open-label, repeated-dose study involving patients who required opioid therapy on a daily basis for chronic pain conditions. In this study, baseline evaluations were performed at Visit 1. Patients were given a diary in which to record daily opioid medication use and daily pain-relief ratings throughout the study. During the time between Visit 1 and Visit 2 patients continued taking their prior oral or transdermal opioid medication for pain. Patients were considered stabilized when during usual activity, the total daily dose of baseline medication remained unchanged, with no more than three opioid breakthrough pain medication doses/day administered, for two consecutive days. Patients returned within 1 week of Visit 1 for Visit 2. During this visit, patient's 24-hour baseline oral opioid dose was converted to hydromorphone at a conversion ratio of approximately 5:1 (oral morphine sulfate to oral hydromorphone HCI mg equivalents). Patients were dispensed OROS hydromorphone HCI slow release tablets and were then increased to acceptable analgesia (pain relief). Eligible stabilized patients requiring a total daily dose of at least 8 mg but no more than 64 mg of OROS hydromorphone HCI slow release (exclusive of breakthrough medication) began the 5-10 day maintenance therapy phase at Visit 3. Morphine sulfate (immediate-release tablets) were provided as breakthrough pain medication. Patients returned to the clinic in the morning following a minimum of 4 days of continuous OROS hydromorphone HCI slow release therapy at a constant daily dose for Visit 4. Upon arrival at the clinic, an initial (trough) blood sample was taken prior to witnessed administration of the usual dosage of OROS hydromorphone HCI slow release. The exact time of the drug administration was documented. Patients were instructed to return the following morning and not to consume food or beverage within 3 hours of their scheduled visit. Patients were instructed not to self administer their OROS hydromorphone HCI slow release the following morning; they were dosed in the clinic. Patients could take immediate release morphine sulfate as needed. Patients returned to the clinic the next morning (visit 5) and remained for a 24-hour period for witnessed dosing and plasma (blood) sampling for pharmacokinetic (metabolism/action) analysis. Dosing and plasma (blood) sampling began 24 hours following the time of dosing at the clinic the previous day. Water (240 mL) was taken with the medication. Immediately prior to each blood draw, patients rated their pain intensity using an 11-point scale and rated their pain intensity from 0 (no pain) to 10 (pain as bad as you can imagine). Blood samples for analysis were drawn at: 0 (prior to dosing), 1,2,4,6,8,10,12,15,18,21 and 24 hours after dosing. Urine output was collected over the 24-hour period from selected patients. Vital signs were taken. At the conclusion of Visit 5 or in the event of early study termination, a Global Evaluation and physical examination were performed. The patient's diary was reviewed with the patient and all unused study medication was collected. Safety assessments included vital signs and physical examination at the start and end of study. OROS Hydromorphone HCL (slow release) 8,16,32,and 64 mg tablets orally. Patients were stabilized on prior opioids then converted to OROS Hydromorphone HCL (slow release) and slowly increased or decreased to adequate analgesia. Then the patients were maintained at that dose for 4 - 10 days. Duration of treatment was up to 31 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.
22

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 1

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who had chronic nonmalignant or chronic cancer pain and were currently receiving strong oral or transdermal opioid analgesics (drug that relieves pain) on a daily basis or patients suitable for advancement of therapy to step 3 on the WHO (World Health Organization) analgesic (drug that relieves pain) ladder
  • Patients who required the opioid equivalent of at least 32 mg but no more than 300 mg of oral morphine sulfate or opioid equivalent (exclusive of breakthrough pain medication) every 24 hours for the management of chronic nonmalignant or cancer pain
  • Patients who were 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 drugs)
  • Patients who were pregnant or breast-feeding.Patients with any dysphagia or unable to swallow tablets, acute abdominal conditions that may be obscured by opioids or gastrointestinal disorders, including pre-existing severe GI narrowing, that may affect the absorption or transit of orally administered drugs
  • Patients with any significant CNS disorder, including but not limited to head injury, intracranial lesion, increased intracranial pressure, seizure disorder, stroke within the past 6 months, and disorders of cognition, and clinically significant impaired hematological function
  • Patients that may be at risk for serious decreases in blood pressure following administration of an opioid analgesic (pain relief)

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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
The pharmacokinetic (absorption, distribution, excretion) profile of OROS hydromorphone. The time required for absorption and distribution in the body.

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
Relationships between pharmacokinetic (absorption, distribution, excretion) and pharmacodynamic (drug action on body systems) responses. Patients rated their pain intensity prior to each time blood was draw.

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.
August 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 (Actual)

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.
February 17, 2017

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.
February 15, 2017

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.
  • CR011620

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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