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To evaluate the efficacy of OROS Hydromorphone in reducing moderate to severe chronic pain in patients with Osteoarthritis (OA) Pain
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OROS Hydromorphone | Experimental | OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg |
|
| Placebo | Placebo Comparator | Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OROS hydromorphone | Drug | hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase | Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated. | Baseline, Week 12 |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity and Change From Baseline by Visit in the Double-blind Phase | Baseline to Week 12 | |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score and Change From Baseline by Visit in the Double-blind Phase |
Inclusion Criteria
Exclusion Criteria
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| ID | Title | Description |
|---|---|---|
| FG000 | OROS Hydromorphone | OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg |
| FG001 | Placebo | Matching placebo tablets orally once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Conversion and Titration Phase |
| |||||||||||||
| Double-blind Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OROS Hydromorphone | OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg |
| BG001 | Placebo | Matching placebo tablets orally once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity Change From Baseline to Week 12 or Final Visit of the Double-blind Phase | Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated. | Intent to treat population defined as all patients randomized to the Double-blind phase who received at least one dose of randomized study medication. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
|
Duration of the trial: 1 year, 4 months
The safety population includes all patients who were enrolled and who took at least one dose of study drug (N=338). Adverse event displays include data from the safety population. The number of subjects who entered the Conversion and Titration phase was 343.
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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 | Conversion and Titration Phase | OROS hydromorphone 12, 16, 24, 32, 40, 48 or 64 mg |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA (11.1) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt | 800-556-3314 | 5 | clinicaltrials@mnk.com |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010003 | Osteoarthritis |
| D010146 | Pain |
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
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| Placebo |
| Drug |
Placebo |
|
| Baseline to Week 12 |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score and Change From Baseline by Visit in the Double-blind Phase | Baseline to Week 12 |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score and Change From Baseline by Visit in the Double-blind Phase | Baseline to Week 12 |
| Patient Global Assessment and Change From Baseline by Visit in the Double-blind Phase | Baseline to Week 12 |
| Time to Treatment Failure From Baseline | within 12 weeks from Baseline |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo |
Matching placebo tablets orally once daily |
|
|
| Other Pre-specified | Patient Diary-derived Numeric Rating Scale (NRS) Pain Intensity and Change From Baseline by Visit in the Double-blind Phase | Not Posted | Baseline to Week 12 | Participants |
| Other Pre-specified | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score and Change From Baseline by Visit in the Double-blind Phase | Not Posted | Baseline to Week 12 | Participants |
| Other Pre-specified | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score and Change From Baseline by Visit in the Double-blind Phase | Not Posted | Baseline to Week 12 | Participants |
| Other Pre-specified | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score and Change From Baseline by Visit in the Double-blind Phase | Not Posted | Baseline to Week 12 | Participants |
| Other Pre-specified | Patient Global Assessment and Change From Baseline by Visit in the Double-blind Phase | Not Posted | Baseline to Week 12 | Participants |
| Other Pre-specified | Time to Treatment Failure From Baseline | Not Posted | within 12 weeks from Baseline | Participants |
| 6 |
| 338 |
| 197 |
| 338 |
| EG001 | Double-blind Phase - Hydromorphone | OROS hydromorphone 12, 16, 24, 32, 40, 48 or 64 mg | 5 | 100 | 68 | 100 |
| EG002 | Double-blind Phase - Placebo | Matching placebo tablets orally once daily | 1 | 100 | 52 | 100 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (11.1) |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (11.1) |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (11.1) |
|
| Oedema peripheral | General disorders | MedDRA (11.1) |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (11.1) |
|
| Pneumonia | Infections and infestations | MedDRA (11.1) |
|
| Septic shock | Infections and infestations | MedDRA (11.1) |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.1) |
|
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA (11.1) |
|
| Chest pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Completed suicide | Psychiatric disorders | MedDRA (11.1) |
|
| Urethral caruncle | Renal and urinary disorders | MedDRA (11.1) |
|
| Embolism | Vascular disorders | MedDRA (11.1) |
|
| Constipation | Gastrointestinal disorders | MedDRA (11.1) |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (11.1) |
|
| Food poisoning | Gastrointestinal disorders | MedDRA (11.1) |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) |
|
| Toothache | Gastrointestinal disorders | MedDRA (11.1) |
|
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) |
|
| Drug withdrawal syndrome | General disorders | MedDRA (11.1) |
|
| Fatigue | General disorders | MedDRA (11.1) |
|
| Oedema peripheral | General disorders | MedDRA (11.1) |
|
| Pyrexia | General disorders | MedDRA (11.1) |
|
| Bronchitis | Infections and infestations | MedDRA (11.1) |
|
| Gastroenteritis | Infections and infestations | MedDRA (11.1) |
|
| Influenza | Infections and infestations | MedDRA (11.1) |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) |
|
| Sinusitis | Infections and infestations | MedDRA (11.1) |
|
| Tooth abscess | Infections and infestations | MedDRA (11.1) |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.1) |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.1) |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1) |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA (11.1) |
|
| Weight decreased | Investigations | MedDRA (11.1) |
|
| Arthralgia | Metabolism and nutrition disorders | MedDRA (11.1) |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) |
|
| Dizziness | Nervous system disorders | MedDRA (11.1) |
|
| Headache | Nervous system disorders | MedDRA (11.1) |
|
| Somnolence | Nervous system disorders | MedDRA (11.1) |
|
| Tremor | Nervous system disorders | MedDRA (11.1) |
|
| Anxiety | Psychiatric disorders | MedDRA (11.1) |
|
| Insomnia | Psychiatric disorders | MedDRA (11.1) |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.1) |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.1) |
|
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| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |