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Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALO-01 | Experimental | Doses given once or twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER) | Drug | capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects With Treatment Emergent Adverse Events | Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product). | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain | Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain. | 12 weeks |
| Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James B. Jones, MD, PharmD | Alpharma Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael Gibson, MD | Birmingham | Alabama | 35244 | United States | ||
| Steven Siwek, MD |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26695349 | Derived | Setnik B, Pixton GC, Webster LR. Safety profile of extended-release morphine sulfate with sequestered naltrexone hydrochloride in older patients: pooled analysis of three clinical trials. Curr Med Res Opin. 2016;32(3):563-72. doi: 10.1185/03007995.2015.1131153. Epub 2016 Jan 26. | |
| 21904098 | Derived | Webster LR, Brewer R, Morris D, Cleveland JM, Setnik B. Opioid titration and conversion in patients receiving morphine sulfate and naltrexone hydrochloride extended release capsules. Postgrad Med. 2011 Sep;123(5):155-64. doi: 10.3810/pgm.2011.09.2471. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ALO-01 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Enrollment |
|
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|
Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain. |
| 52 weeks |
| Phoenix |
| Arizona |
| 85027 |
| United States |
| Michael Loes, MD | Phoenix | Arizona | 85032 | United States |
| Allan Soo, MD | Tempe | Arizona | 85282 | United States |
| Leah Schmidt, DO | Tucson | Arizona | 85741 | United States |
| Steve Sitar, MD | Anaheim | California | 92801 | United States |
| Robert Burton, MD | Anaheim | California | 92804 | United States |
| Arturo Palencia, MD | Bakersfield | California | 93311 | United States |
| Adam Karnes, MD | Beverly Hills | California | 90211 | United States |
| Douglas Haselwood, MD | Fair Oaks | California | 95628 | United States |
| Steven Croft, MD | Delray Beach | Florida | 33484 | United States |
| Roberto Rodriquez, MD | Hialeah | Florida | 33013 | United States |
| Orlando Florete, MD | Jacksonville | Florida | 32257 | United States |
| Michael Link, MD | Kissimmee | Florida | 34741 | United States |
| Miguel Trevino, MD | Largo | Florida | 33770 | United States |
| Diego Torres II, MD | Ormond Beach | Florida | 32174 | United States |
| Martin Hale, MD | Plantation | Florida | 33324 | United States |
| Margarita Nunez, MD | St. Petersburg | Florida | 33702 | United States |
| Mary Stedman, MD | Tampa | Florida | 33613 | United States |
| Raymond Tidman, MD | Blue Ridge | Georgia | 30513 | United States |
| Arnold Weil | Marietta | Georgia | 30060 | United States |
| Marvin Tark | Marietta | Georgia | 30066 | United States |
| Azazuddin Ahmed, MD | Chicago | Illinois | 60616 | United States |
| Jenecsis Castro-Skoglund, MD | Peoria | Illinois | 61614 | United States |
| Steven Elliott, MD | Evansville | Indiana | 47714 | United States |
| John Peppin, DO | West Des Moines | Iowa | 50265 | United States |
| Randall Brewer, MD | Shreveport | Louisiana | 71103 | United States |
| David Miller, MD | North Dartmouth | Massachusetts | 02747 | United States |
| Adnan Dahdul, MD | Springfield | Massachusetts | 01103 | United States |
| Rebecca Baumbach, MD | Saginaw | Michigan | 48602 | United States |
| Mel Lucas, MD | Florissant | Missouri | 63031 | United States |
| Anthony Margherita, MD | St Louis | Missouri | 63141 | United States |
| Randale Sechrest, MD | Missoula | Montana | 59802 | United States |
| John Jacobson, MD | Omaha | Nebraska | 68134 | United States |
| James Meli, DO | Henderson | Nevada | 89014 | United States |
| Stephen Miller, MD | Las Vegas | Nevada | 89106 | United States |
| Vrijendra Kumar, MD | Las Vegas | Nevada | 89123 | United States |
| Christopher Colopinto, MD | Voorhees Township | New Jersey | 08043 | United States |
| Barbara McGuire, MD | Albuquerque | New Mexico | 87108 | United States |
| Arthur Elkind, MD | Mount Vernon | New York | 10550 | United States |
| Patrick Box, MD | Charlotte | North Carolina | 28210 | United States |
| Richard Rauck, MD | Winston-Salem | North Carolina | 27103 | United States |
| Thomas Littlejohn III, MD | Winston-Salem | North Carolina | 27103 | United States |
| Bruce Corser, MD | Cincinnati | Ohio | 45227 | United States |
| Gregory Gottschlich, MD | Cincinnati | Ohio | 45242 | United States |
| Robert Kalb, MD | Toledo | Ohio | 43623 | United States |
| Tanna Shaw, MD | Oklahoma City | Oklahoma | 73116 | United States |
| Joseph Dunn, MD | Eugene | Oregon | 97401 | United States |
| Lawrence Levinson, MD | Tipton | Pennsylvania | 16684 | United States |
| William Travis Ellison, MD | Greer | South Carolina | 29651 | United States |
| William Smith, MD | Knoxville | Tennessee | 37920 | United States |
| Lee Carter, MD | Milan | Tennessee | 38358 | United States |
| Walter Chase, MD | Austin | Texas | 78705 | United States |
| Andrew Klymiuk, MD | Richardson | Texas | 75080 | United States |
| Francis Burch, MD | San Antonio | Texas | 78217 | United States |
| Suzanne Gazda, MD | San Antonio | Texas | 78229 | United States |
| Webster Lynn, MD | Salt Lake City | Utah | 84106 | United States |
| Richard Eckert, MD | Roanoke | Virginia | 24018 | United States |
| 21075272 | Derived | Webster LR, Brewer R, Wang C, Sekora D, Johnson FK, Morris D, Stauffer J. Long-term safety and efficacy of morphine sulfate and naltrexone hydrochloride extended release capsules, a novel formulation containing morphine and sequestered naltrexone, in patients with chronic, moderate to severe pain. J Pain Symptom Manage. 2010 Nov;40(5):734-46. doi: 10.1016/j.jpainsymman.2010.05.004. |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ALO-01 |
| 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 | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Brief Pain Inventory (BPI) Average Pain | All patients reporting a BPI average pain score (over last 24 hours: 0=no pain, 10=worst pain) at baseline | Mean | Standard Deviation | Units on scale |
|
| 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 | Subjects With Treatment Emergent Adverse Events | Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product). | Patients treated with study drug | Posted | Number | participants | up to 12 months |
|
|
| ||||||||||||||||||||||||||
| Secondary | Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain | Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain. | Patients with data at Week 12 | Posted | Mean | Standard Deviation | Percent change | 12 weeks |
|
|
| |||||||||||||||||||||||||
| Secondary | Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain | Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain. | Patients with data at Week 52 | Posted | Mean | Standard Deviation | Percent change | 52 weeks |
|
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|
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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 | ALO-01 | 33 | 465 | 265 | 465 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac failure congestive | Cardiac disorders | Systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrointestinal inflammation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancreatitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Cholelithiasis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Arthritis bacterial | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis acute | Infections and infestations | Systematic Assessment |
| ||
| Ankle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Overdose (insulin) | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Ketosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Invertebral disc protrusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Breast cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Carotid artery stenosis | Nervous system disorders | Systematic Assessment |
| ||
| Lumbar radiculopathy | Nervous system disorders | Systematic Assessment |
| ||
| Transient ischaemic attack | Nervous system disorders | Systematic Assessment |
| ||
| Conversion disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Somatoform disorder | Psychiatric disorders | Systematic Assessment |
| ||
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
| ||
| Appendicectomy | Surgical and medical procedures | Systematic Assessment |
| ||
| Hip surgery | Surgical and medical procedures | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Peripheral vascular disorder | Vascular disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Somnolence | Nervous system disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the Sponsor for review. Sponsor may request a delay in publication to allow the filing of patent applications before publication or release. The sponsor can require deletion of Confidential Information or request correction of inaccuracies.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Development | King Pharmaceuticals Research and Development, Inc. | 919-653-7001 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D059350 | Chronic Pain |
| D018771 | Arthralgia |
| D001416 | Back Pain |
| D051474 | Neuralgia, Postherpetic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D009437 | Neuralgia |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C550436 | morphine, naltrexone combination |
| D009020 | Morphine |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| 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 |
| D009270 | Naloxone |
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| Physician Decision |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Drug Screen |
|
| Administrative |
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| Sponsor Decision |
|
| Multiple Reasons |
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| Denominators |
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