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:
Janssen-Cilag International NV
ClinicalTrials.gov Identifier:
NCT00980798
First received: September 18, 2009
Last updated: May 18, 2011
Last verified: March 2011

September 18, 2009
May 18, 2011
October 2007
November 2008   (final data collection date for primary outcome measure)
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".
The primary efficacy outcome measure will be assessed by recording each patient's score at clinic visits at each time point in the Brief Pain Inventory (BPI) item 5 (pain on average). Assessments will be made throughout the study. [ Time Frame: Visit 0 at week -1, visit 1 at week 0, visit 2 at week 1, visit 3 at week 2, visit 4 at week 3, visit 5 at week 4, visit 6 at week 8, visit 7 at week 12, visit 8 at week 16. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00980798 on ClinicalTrials.gov Archive Site
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.
  • To assess drop-out rate due to adverse effect and to compare that rate for active treatment versus placebo [ Time Frame: Visit 2 at week 1, visit 3 at week 2, visit 4 at week 3, visit 5 at week 4, visit 6 at week 8, visit 7 at week 12, visit 8 at week 16 ] [ Designated as safety issue: No ]
  • To asses the effect of treatment on physical functionality, on pain control and quality of life [ Time Frame: Visit 1 at week 0, visit 5 at week 4, visit 6 at week 8, visit 7 at week 12, visit 8 at week 16 ] [ Designated as safety issue: No ]
  • To assess the effect of treatment on sleep quality [ Time Frame: Visit 1 at week 0, visit 8 at week 16 ] [ Designated as safety issue: No ]
  • To assess overall safety and tolerability [ Time Frame: Visit 2 at week 1, visit 3 at week 2, visit 4 at week 3, visit 5 at week 4, visit 6 at week 8, visit 7 at week 12, visit 8 at week 16 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Pain
  • Osteoarthritis, Hip
  • Osteoarthritis, Knee
  • Drug: OROS hydromorphone HCl
    4 to 32 mg taken orally once daily for 16 weeks
  • Drug: Placebo
    placebo tablet once daily for 16 weeks
  • Experimental: 001
    OROS hydromorphone HCl 4 to 32 mg taken orally once daily for 16 weeks
    Intervention: Drug: OROS hydromorphone HCl
  • Placebo Comparator: 002
    Placebo placebo tablet once daily for 16 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
288
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00980798
CR012601, HOP Trial
Not Provided
EMEA Medical Affairs Director Analgesia, Janssen-Cilag Ltd.
Janssen-Cilag International NV
Not Provided
Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
Janssen-Cilag International NV
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP