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| ID | Type | Description | Link |
|---|---|---|---|
| B2541005 |
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| Name | Class |
|---|---|
| Progenics Pharmaceuticals, Inc. | INDUSTRY |
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This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylnaltrexone | Experimental | Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; or 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information. |
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| Placebo | Placebo Comparator | Placebo subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL every other day if weight ≥ 62kg; or 0.4 mL every other day if weight between 38 and < 62 kg. Subjects with impaired kidney function received reduced volumes of placebo solution to match the volumes used in the experimental group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylnaltrexone | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses | This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Rescue-free Laxation (Following the First Dose of Study Drug). | This outcome measures the time from first dose of study drug to the first rescue-free laxation (ie, bowel movement). A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enoch Bortey | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salix Investigational Site | Mobile | Alabama | 36604 | United States | ||
| Salix Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33788162 | Derived | Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31. | |
| 27573565 | Derived | Janku F, Johnson LK, Karp DD, Atkins JT, Singleton PA, Moss J. Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer. Ann Oncol. 2016 Nov;27(11):2032-2038. doi: 10.1093/annonc/mdw317. Epub 2016 Aug 29. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylnaltrexone Bromide | Methylnaltrexone bromide: Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses). |
| FG001 | Placebo | Placebo: Placebo subcutaneously every other day for 14 days (ie, 7 doses). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
|
| Laguna Hills |
| California |
| 92637 |
| United States |
| Salix Investigational Site | Lancaster | California | 93534 | United States |
| Salix Investigational Site | Aurora | Colorado | 80045 | United States |
| Salix Investigational Site | Auburndale | Florida | 33823 | United States |
| Salix Investigational Site | Hudson | Florida | 34667 | United States |
| Salix Investigational Site | Lakeland | Florida | 33805 | United States |
| Salix Investigational Site | Lakeland | Florida | 33815 | United States |
| Salix Investigational Site | Miami Springs | Florida | 33166 | United States |
| Salix Investigational Site | Ruskin | Florida | 33573 | United States |
| Salix Investigational Site | Sebring | Florida | 33870 | United States |
| Salix Investigational Site | Tampa | Florida | 33609 | United States |
| Salix Investigational Site | Tampa | Florida | 33612-9416 | United States |
| Salix Investigational Site | Tampa | Florida | 33619 | United States |
| Salix Investigational Site | Temple Terrace | Florida | 33617 | United States |
| Salix Investigational Site | West Palm Beach | Florida | 33407 | United States |
| Salix Investigational Site | Orange | New Jersey | 07018 | United States |
| Salix Investigational Site | Albuquerque | New Mexico | 87108 | United States |
| Salix Investigational Site | Flat Rock | North Carolina | 28731 | United States |
| Salix Investigational Site | Winston-Salem | North Carolina | 27103-5766 | United States |
| Salix Investigational Site | Cleveland | Ohio | 44119 | United States |
| Salix Investigational Site | Philadelphia | Pennsylvania | 19111 | United States |
| Salix Investigational Site | Austin | Texas | 78757 | United States |
| Salix Investigational Site | Houston | Texas | 77030 | United States |
| Salix Investigational Site | American Fork | Utah | 84003 | United States |
| Salix Investigational Site | Orem | Utah | 84058 | United States |
| Salix Investigational Site | Provo | Utah | 84604 | United States |
| Salix Investigational Site | Salt Lake City | Utah | 84112 | United States |
| Salix Investigational Site | Madison | Wisconsin | 53792 | United States |
| Salix Investigational Site | Darlinghurst | New South Wales | 2010 | Australia |
| Salix Investigational Site | Coburg | Victoria | 3058 | Australia |
| Salix Investigational Site | East Melbourne | Victoria | 3002 | Australia |
| Salix Investigational Site | Leuven | B-3000 | Belgium |
| Salix Investigational Site | Liberdade | São Paulo | 01509-900 | Brazil |
| Salix Investigational Site | São Paulo | São Paulo | 01508-010 | Brazil |
| Salix Investigational Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Salix Investigational Site | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Salix Investigational Site | Hamilton | Ontario | L8M 1W9 | Canada |
| Salix Investigational Site | Montreal | Quebec | H3A 1A1 | Canada |
| Salix Investigational Site | Montreal | Quebec | H3T 1E2 | Canada |
| Salix Investigational Site | Québec | Quebec | G1R 3S1 | Canada |
| Salix Investigational Site | Besançon | 25030 | France |
| Salix Investigational Site | Bordeaux | 33075 | France |
| Salix Investigational Site | Bordeaux | 33604 | France |
| Salix Investigational Site | Grenoble | 38043 | France |
| Salix Investigational Site | Montpellier | 34295 | France |
| Salix Investigational Site | Villejuif | 94804 | France |
| Salix Investigational Site | Aachen | 52074 | Germany |
| Salix Investigational Site | Berlin | 14089 | Germany |
| Salix Investigational Site | München | 80336 | Germany |
| Salix Investigational Site | L’Aquila | 67100 | Italy |
| Salix Investigational Site | Milan | 20020 | Italy |
| Salix Investigational Site | Milan | 20133 | Italy |
| Pfizer Investigational Site | Mexico City DF | 03600 | Mexico |
| Salix Investigational Site | Barcelona | 08036 | Spain |
| Salix Investigational Site | L'Hospitalet de Llobregat | 8097 | Spain |
| Salix Investigational Site | Seville | 41013 | Spain |
| Salix Investigational Site | Kungsbacka | 434 80 | Sweden |
| Salix Investigational Site | Norrköping | 60185 | Sweden |
| Salix Investigational Site | Cheltenham | Gloucestershire | GL53 0Qj | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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The analysis population included subjects who received ≥ 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylnaltrexone Bromide | Methylnaltrexone bromide: Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses). |
| BG001 | Placebo | Placebo: Placebo subcutaneously every other day for 14 days (ie, 7 doses). |
| BG002 | Total | Total of all reporting groups |
| 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 |
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| Underlying Advanced Illness | Number | participants |
| ||||||||||||||||||
| Weight | Number | participants |
| ||||||||||||||||||
| Glomerular filtration rate | Number | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses | This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation. | The analysis population included subjects who received ≥ 1 dose of study drug. | Posted | Number | 95% Confidence Interval | percentage of participants | 7 days |
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| Secondary | Time to First Rescue-free Laxation (Following the First Dose of Study Drug). | This outcome measures the time from first dose of study drug to the first rescue-free laxation (ie, bowel movement). A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation. | The analysis population included subjects who received ≥ 1 dose of study drug. | Posted | Median | Inter-Quartile Range | hours | 14 days |
|
|
14 days
Adverse events were collected by non-systematic (patient reports) and systematic methods (investigator examinations and lab tests). For both adverse events tables, a subject reporting more than one adverse event for a particular MedDRA preferred term or system organ class was counted only once for that MedDRA preferred term or system organ class.
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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 | Methylnaltrexone Bromide | Methylnaltrexone bromide: Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses). | 14 | 116 | 66 | 116 | ||
| EG001 | Placebo | Placebo: Placebo subcutaneously every other day for 14 days (ie, 7 doses). | 24 | 114 | 52 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Disease progression | General disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Systematic Assessment |
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| Hypercalcemia | Metabolism and nutrition disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Hyponatremia | Metabolism and nutrition disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 14.0 | Systematic Assessment |
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| Spinal cord compression | Nervous system disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Disorientation | Psychiatric disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Edema peripheral | General disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 14.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA Version 14.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Sorscher | Salix | 919-862-1827 | david.sorscher@salix.com |
| ID | Term |
|---|---|
| D000079689 | Opioid-Induced Constipation |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C032257 | methylnaltrexone |
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| >=65 years |
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| Male |
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| Pulmonary disease (other than malignancy) |
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| Cardiovascular disease |
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| Neurologic disease |
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| Other |
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| ≥ 62 kg |
|
| ≥ 30 mL/min/1.73 m^2 |
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| Missing |
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