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| ID | Type | Description | Link |
|---|---|---|---|
| 42801PAI4008 |
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the study was stopped due to non-availability of 4mg
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The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorphone using standardized conversion from prior opioid therapy among participants with cancer pain.
This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than one center) study to evaluate the effectiveness and safety of stable dose of OROS hydromorphone among participants with cancer pain. The duration of this study will be 28 days and will include visits at: Day 0 (Baseline), Day 7, 14 and 28. The OROS hydromorphone will be administered orally for 28 days and dose titration (incremental increase in drug dosage to a level that provides the optimal therapeutic effect) will be done every two days upon administration of dose. Rescue medication (a medication intended to relieve symptoms immediately) of morphine will be permitted throughout the study duration. Efficacy of the participants will primarily be evaluated by Brief Pain Inventory score. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osmotic Release Oral System (OROS) Hydromorphone | Experimental | OROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and dose will be increased if needed, but not more than 40 mg and not more frequently than every two days. The study drug will be administered up to 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osmotic Release Oral System (OROS) hydromorphone | Drug | OROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and dose will be increased if needed, but not more than 40 mg and not more frequently than every two days. The study drug will be administered up to 28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (BPI) Average Score at Baseline | The Brief Pain Inventory (BPI) assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely. | Baseline |
| Brief Pain Inventory (BPI) Average Score at Day 28 | The BPI assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Given Rescue Pain Medications | Rescue medication was a medication intended to relieve symptoms immediately. Rescue medication of morphine was used during the study duration and dose was set at 10-15 percent of the total daily morphine dose which ranged from 10-60 milligram. | Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutica Clinical Trial | Janssen Pharmaceutica | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Osmotic Release Oral System (OROS) Hydromorphone | Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Osmotic Release Oral System (OROS) Hydromorphone | Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Brief Pain Inventory (BPI) Average Score at Baseline | The Brief Pain Inventory (BPI) assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely. | Intent-to-treat (ITT) population included all participants who received at least one dose of study medication at Baseline. | Posted | Mean | Standard Deviation | Units on a scale | Baseline |
|
Baseline up to Day 28
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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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 | OROS Hydromorphone | OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
The study was prematurely terminated due to administrative reason.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Manager | Janssen Philippines | +632-8248935 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
|
| Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician |
The Clinical Global Impression (CGI) rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant, which ranges from "very much worse" to "very much improved" (as compared to Baseline). |
| Day 28 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | OROS Hydromorphone 12 mg | OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days. |
| OG002 | OROS Hydromorphone 16 mg | OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days. |
| OG003 | OROS Hydromorphone 20 mg | OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days. |
| OG004 | OROS Hydromorphone 24 mg | OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days. |
| OG005 | OROS Hydromorphone 32 mg | OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days. |
| OG006 | OROS Hydromorphone 36 mg | OROS Hydromorphone was administered as 36 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days. |
|
|
| Primary | Brief Pain Inventory (BPI) Average Score at Day 28 | The BPI assesses the severity of pain and the impact of pain on daily functions (interference items). The severity items are scored from 0=no pain and 10=pain as bad as you can imagine. The interference items are scored from 0=no interference and 10=interferes completely. | ITT population included all participants who received at least one dose of study medication at Baseline. 'N ' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | Units on a scale | Day 28 |
|
|
|
| Secondary | Number of Participants Given Rescue Pain Medications | Rescue medication was a medication intended to relieve symptoms immediately. Rescue medication of morphine was used during the study duration and dose was set at 10-15 percent of the total daily morphine dose which ranged from 10-60 milligram. | ITT population included all participants who received at least one dose of study medication at Baseline. 'N ' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Number | Participants | Day 28 |
|
|
|
| Secondary | Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician | The Clinical Global Impression (CGI) rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant, which ranges from "very much worse" to "very much improved" (as compared to Baseline). | ITT population included all participants who received at least one dose of study medication at Baseline. "n" signifies those participants who were evaluated for this measure at the specified time point. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | Participants | Day 28 |
|
|
|
| 2 |
| 20 |
| 9 |
| 20 |
| Hypehidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Death due to sepsis | Infections and infestations | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
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| Chest Discomfort | General disorders | MedDRA Version 15.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 15.1 | Non-systematic Assessment |
|
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| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Severity item: Least pain in last 24 hours |
|
| Severity item: Average pain |
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| Severity item: Pain right now |
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| Interference item: General activity |
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| Interference item: Mood |
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| Interference item: Talking ability |
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| Interference item: Normal work |
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| Interference item: Relationships with other people |
|
| Interference item: Sleep |
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| Interference item: Enjoyment of life |
|
| Title | Measurements |
|---|---|
|
| No change: Day 28 (n=15) |
|
| Minimally worse: Day 28 (n=15) |
|
| Very much worse: Day 28 (n=15) |
|
| Not evaluated: Day 28 (n=15) |
|