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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT00980798
First received: September 18, 2009
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Pain
Osteoarthritis, Hip
Osteoarthritis, Knee
Drug: OROS hydromorphone HCl
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag International NV:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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".


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The number of patients dropping out of the study owing to adverse events will be presented for each treatment group.


Enrollment: 288
Study Start Date: October 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980798

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
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT00980798     History of Changes
Other Study ID Numbers: CR012601, HOP Trial
Study First Received: September 18, 2009
Results First Received: August 12, 2010
Last Updated: April 8, 2014
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen-Cilag International NV:
Osteoarthritis
Strong pain killer
Strong opioid
Low starting dose
Fewer side effects
Physical functioning
Pain control
Quality of life
Sleep quality

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014