Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee

April 8, 2014 updated by: Janssen-Cilag International NV

Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Investigate the Analgesic Effect of OROS Hydromorphone Hydrochloride in Comparison With Placebo in Subjects With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee

This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who are suffering from pain due to osteoarthritis of the hip or the knee and who previously did not receive any strong opioids.The clinical trial tests the effect of the treatment on symptoms of pain, stiffness and physical function. The effect of the treatment on parameters on health related quality of life as well as quality of sleep will be measured.

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

In this clinical trial subjects are enrolled, who are suffering from pain due to osteoarthritis of the hip or the knee that is not sufficiently controlled with either a non steroidal anti-inflammatory drug (NSAID) or paracetamol or a weak opioid. This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who previously did not receive any strong opioids. The drug class of opioid analgesics can broadly be classified into strong and weak. Weak opioids (for example tramadol, codeine, dihydrocodeine and tilidine) are useful for mild to moderate pain and the strong opioids (for example morphine, fentanyl and hydromorphone) are useful for moderate to severe pain of different origin. OROS hydromorphone is an opioid, which is available in a prolonged-release tablet in different dosage strengths. The primary aim of the study is to test the efficacy of OROS hydromorphone against placebo at an individual dose sufficient to control the pain and to establish the usefulness of a new low-dose formulation of OROS hydromorphone (4 mg hydromorphone per tablet) for initiating the treatment and for dose titration. The clinical trial tests the effect of the treatment on symptoms of pain, stiffness and physical function. The effect of the treatment on parameters on health related quality of life as well as quality of sleep will be measured. The safety of the treatment will be recorded by measuring blood pressure, heart rate, and respiratory rate.This clinical trial is a placebo-controlled trial, meaning that one group of patients will receive the drug to be tested (OROS hydromorphone) while the control group receives an optically identical tablet with no active ingredient, a so-called placebo. A total number of 270 patients will be enrolled in this clinical trial and assigned to one of two treatment arms at an equal ratio (i.e. 135 patients per treatment). Patients will be randomly assigned to one of the two treatment arms, like flipping a coin to decide which treatment they will receive. Neither the patient nor the doctor will know to which of the two treatment arms the patient is assigned to and neither the patient nor the doctor can influence the assignment to the treatment arm. During the whole treatment period paracetamol will be allowed to be taken as needed in case of pain. Medical history and physical exam will be conducted during the screening visit, followed in 1 week by the baseline visit where after completing several questionnaires assessing pain, physical functioning quality of life and sleep quality, the patient will be assigned to one of two treatment groups. After starting the study treatment the patient will visit the doctor 7 times: at week 1, 2, 3, 4, 8, 12, 16 and at a follow-up visit after the end of the treatment period at week 16. At week 16 questionnaires will again be completed and the results will be compared to the baseline findings. 4, 8, 12, 16, 24 or 32 mg of OROS hydromorphone tablets or matching placebo tablets taken for 16 weeks. All tablets are taken by mouth at the same time each day in the morning. Tablets have to be swallowed whole without chewing or crushing. After completion of the treatment duration (or at early withdrawal), the study medication is gradually tapered down over a maximum of 6 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.
288

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Klatovy, Czech Republic
      • Olomouc, Czech Republic
      • Pelhøimov, Czech Republic
      • Praha 2, Czech Republic
      • Praha 3, Czech Republic
      • Roudnice Nad Labem, Czech Republic
  • Romania
      • Bucharest, Romania
      • Bucuresti, Romania
      • Cluj-Napoca, Romania
      • Iasi, Romania
  • Slovakia
      • Bratislava, Slovakia
      • Hlohovec, Slovakia
      • Piestany, Slovakia
  • United Kingdom
      • London, United Kingdom

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

36 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Documented Osteoarthritis of the hip or knee
  • Chronic pain for more than 3 months treated with daily analgesic for the last month
  • Moderate to severe OA pain of the target joint, which cannot be adequately treated with non-steroidal anti-inflamatory drugs or paracetamol
  • Moderate to severe pain by means of a mean weekly score of >= 5 in the Brief Pain Invetory item 5 'pain on average'

Exclusion Criteria:

  • Regular treatment with an opioid in the 4 weeks before screening visit (infrequent use of tramadol, codeine, tilidine, or dihydrocodeine for no more than 10 days in the 4 weeks before the screening visit is acceptable, however, treatment must be stopped at screening visit)
  • Diagnosis of major depression
  • Treatment for epilepsy
  • Corticosteroid injection within the last 3 months
  • Major surgery in the 3 months before the start of the study
  • Women who are pregnant or breast-feeding

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: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: 001
OROS hydromorphone HCl 4 to 32 mg taken orally once daily for 16 weeks
Drug: OROS hydromorphone HCl
4 to 32 mg taken orally once daily for 16 weeks
Placebo Comparator: 002
Placebo placebo tablet once daily for 16 weeks
Drug: Placebo
placebo tablet once daily for 16 weeks

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
Measure Description
Time Frame
Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average)
Time Frame: At each study visit from screening to week 16
The analgesic effect was assessed by the BPI item 5 "pain on average" using a 0 to 10 numeric rating scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine".
At each study visit from screening to week 16

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
Measure Description
Time Frame
The Number of Patients Discontinuing From the Trial Due to the Occurrence of an Adverse Event
Time Frame: At each study visit from baseline until week 16
The number of patients dropping out of the study owing to adverse events will be presented for each treatment group.
At each study visit from baseline until week 16

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.
Janssen-Cilag International NV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2008

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.
November 1, 2008

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).
September 18, 2009

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.
September 18, 2009

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.
September 21, 2009

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 25, 2014

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 8, 2014

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, 2014

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.
  • CR012601
  • HOP Trial

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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