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| ID | Type | Description | Link |
|---|---|---|---|
| B2541006 |
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| Name | Class |
|---|---|
| Progenics Pharmaceuticals, Inc. | INDUSTRY |
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This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylnaltrexone bromide | Experimental | Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study. 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylnaltrexone bromide | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Laxations Per Subject Within 24 Hours of Dosing Per Week. | This was defined as the total number of days with a laxation (ie, a bowel movement) within 24 hours after dosing in each 7-day interval after the start of dosing. Results shown are the ranges (lowest and highest weekly values) of mean (± standard deviation) numbers of laxations within 24 hours of dosing per week during the 10-week treatment period for each group. | 10 weeks |
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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 |
The main eligibility criteria for this study were completion of 2 weeks of therapy and all post-baseline efficacy, safety, and health outcomes assessments in lead-in study MNTX4000 and an anticipated continued need for treatment of opioid-induced constipation.
Patients participated in this study at sites in Australia, Belgium, Brazil, Canada, France, Germany, Italy, Mexico, Spain, Sweden, the United Kingdom, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylnaltrexone Bromide 8 mg | Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study. Subjects received 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | Orange | New Jersey | 07018 | 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 | Madison | Wisconsin | 53792 | United States |
| Salix Investigational Site | Coburg | Victoria | 3058 | Australia |
| Salix Investigational Site | East Melbourne | Victoria | 3002 | Australia |
| Salix Investigational Site | Adelaide | 5000 | Australia |
| Salix Investigational Site | Leuven | B-3000 | Belgium |
| Salix Investigational Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Salix Investigational Site | Edmonton | Alberta | T6L 5X8 | Canada |
| Salix Investigational Site | Hamilton | Ontario | L8M 1W9 | Canada |
| Salix Investigational Site | London | Ontario | N6A 4L6 | Canada |
| Salix Investigational Site | Montreal | Quebec | H3A 1A1 | Canada |
| Salix Investigational Site | Québec | Quebec | G1R 3S1 | Canada |
| Salix Investigational Site | Montpellier | 34295 | France |
| Salix Investigational Site | Berlin | 14089 | Germany |
| Salix Investigational Site | L’Aquila | 67100 | Italy |
| Salix Investigational Site | Milan | 20020 | Italy |
| Salix Investigational Site | Milan | 20133 | Italy |
| Salix Investigational Site | Roma | 00144 | Italy |
| Pfizer Investigational Site | Mexico City DF | 03600 | Mexico |
| Salix Investigational Site | Almada | 2801-951 | Portugal |
| Salix Investigational Site | Porto | 4200-072 | Portugal |
| Salix Investigational Site | Cheltenham | Gloucestershire | GL53 0QJ | United Kingdom |
| FG001 |
| Methylnaltrexone Bromide 12 mg |
Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study. Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information. |
| COMPLETED |
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| NOT COMPLETED |
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|
The analysis population included subjects who received study drug and had laxation data and drug administration data. Two subjects in the 12 mg/day group had no drug administration data and were not included in efficacy analyses (but they were included in baseline characteristics and safety analyses).
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylnaltrexone Bromide 8 mg | Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study. Subjects received 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. |
| BG001 | Methylnaltrexone Bromide 12 mg | Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study. Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information. |
| 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 |
| ||||||||||||||||||
| Underlying Advanced Illness | Number | Participants |
| ||||||||||||||||||
| Weight | Number | participants |
| ||||||||||||||||||
| Glomerular filtration rate | Number | 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 | Number of Laxations Per Subject Within 24 Hours of Dosing Per Week. | This was defined as the total number of days with a laxation (ie, a bowel movement) within 24 hours after dosing in each 7-day interval after the start of dosing. Results shown are the ranges (lowest and highest weekly values) of mean (± standard deviation) numbers of laxations within 24 hours of dosing per week during the 10-week treatment period for each group. | The analysis population included subjects who received study drug and had laxation data and drug administration data. Two subjects in the 12 mg/day group had no drug administration data and were not included in efficacy analyses (but they were included in baseline characteristics and safety analyses). | Posted | Mean | Standard Deviation | Number of laxations | 10 weeks |
|
|
|
Adverse events were collected over the 10-week treatment period.
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 8 mg | Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study. Subjects received 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. | 22 | 57 | 45 | 57 | ||
| EG001 | Methylnaltrexone Bromide 12 mg | Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study. Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information. | 37 | 92 | 60 | 92 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (14.0) | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Campylobacter infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
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| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (14.0) | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (14.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Sorscher | Salix Pharmaceuticals | 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 |
Not provided
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| >=65 years |
|
| Male |
|
| Pulmonary disease |
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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 |
|
| Missing |
|