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| ID | Type | Description | Link |
|---|---|---|---|
| HOP Trial |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | OROS hydromorphone HCl 4 to 32 mg taken orally once daily for 16 weeks |
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| 002 | Placebo Comparator | Placebo placebo tablet once daily for 16 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OROS hydromorphone HCl | Drug | 4 to 32 mg taken orally once daily for 16 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients Discontinuing From the Trial Due to the Occurrence of an Adverse Event | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag International NV Clinical Trial | Janssen-Cilag International NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klatovy | Czechia | |||||
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| Label | URL |
|---|---|
| Placebo-controlled trial with OROS hydromorphone hydrochloride to treat patients with moderate to severe pain induced by osteoarthritis of the hip or the knee. | View source |
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The first subject attended the first study visit on 05 October 2007, and the last subject completed the last study visit on 24 November 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo daily for 16 weeks |
| FG001 | OROS Hydromorphone HCl | 4 to 32 mg taken orally once daily for 16 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo |
| Drug |
placebo tablet once daily for 16 weeks |
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| Olomouc |
| Czechia |
| Pelhøimov | Czechia |
| Prague | Czechia |
| Roudnice nad Labem | Czechia |
| Bucharest | Romania |
| Cluj-Napoca | Romania |
| Iași | Romania |
| Bratislava | Slovakia |
| Hlohovec | Slovakia |
| Piešťany | Slovakia |
| London | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo daily for 16 weeks |
| BG001 | OROS Hydromorphone HCl | 4 to 32 mg taken orally once daily for 16 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average) | 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 population for the efficacy analyses was the intention to treat (ITT) population: all randomised patients who received at least one dose of study drug excluding patients who had no post-baseline efficacy data. This population included patients who discontinued early owing to lack of efficacy or other reasons. | Posted | Mean | Standard Deviation | units on a scale | At each study visit from screening to week 16 |
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| Secondary | The Number of Patients Discontinuing From the Trial Due to the Occurrence of an Adverse Event | The number of patients dropping out of the study owing to adverse events will be presented for each treatment group. | Safety population: All randomised patients who received at least one dose of study drug. | Posted | Number | participants | At each study visit from baseline until week 16 |
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Adverse were collected from signing of informed consent until the end of the study (week 16 or later after complete tapering off of study medication)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo daily for 16 weeks | 7 | 149 | 50 | 149 | ||
| EG001 | OROS Hydromorphone HCl | 4 to 32 mg taken orally once daily for 16 weeks | 4 | 139 | 106 | 139 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Cardioversion | Surgical and medical procedures | MedDRA 11.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
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Concomitant and rescue medication were permitted in the study. This may be why the results in the placebo arm so closely resemble those in the treatment arm. Patients were also less severely impacted by the underlying disease than in other studies.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| EMEA Medical Affairs Director Analgesia | Janssen-Cilag Ireland | 0035 878 339174 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D015207 | Osteoarthritis, Hip |
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D000377 | Agnosia |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Visit 2 |
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| Visit 3 |
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| Visit 4 |
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| Visit 5 |
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| Visit 6 |
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| Visit 7 |
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| Visit 8 |
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| Visit 9 |
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The analysis was adjusted for baseline BPI item 5 score, time on study, and whether the primary affected joint was the hip or knee. |
| No |
| Superiority or Other |
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