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This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylnaltrexone | Experimental | Participants will receive single dose of MNTX 0.15 milligrams per kilogram (mg/kg) subcutaneously (SC). Subsequent dosing could be adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylnaltrexone | Drug | Methylnaltrexone will be administered as per the dose and schedule specified in the arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Opioid Induced Side Effects | Opioid induced side effects included nausea, myoclonus, mental clouding (confusional state), vomiting, sedation, pruritus, sweating (hyperhidrosis), constipation, and urinary retention. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | From start of treatment until end of study (up to maximum 3.4 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsey Mathew | Bausch Health Companies | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Progenics Pharmaceuticals, Inc. | Tarrytown | New York | 10591 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylnaltrexone | Participants received single dose of methylnaltrexone (MNTX) 0.15 milligrams per kilogram (mg/kg) subcutaneously (SC) initially. Subsequent dosing was adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. Median treatment duration was 25 days. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants who provided a signed and dated written informed consent form (ICF).
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylnaltrexone | Participants received single dose of MNTX 0.15 mg/kg SC initially. Subsequent dosing was adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. Median treatment duration was 25 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 age data of safety evaluable participants (all enrolled participants who received at least one dose of study drug) was calculated and reported. |
| 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 Participants With Opioid Induced Side Effects | Opioid induced side effects included nausea, myoclonus, mental clouding (confusional state), vomiting, sedation, pruritus, sweating (hyperhidrosis), constipation, and urinary retention. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. | All enrolled participants who provided a signed and dated written ICF. | Posted | Count of Participants | Participants | From start of treatment until end of study (up to maximum 3.4 years) |
|
From start of treatment until end of study (up to maximum 3.4 years)
Safety evaluable participants included all enrolled participants who received at least one dose of study drug.
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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 | Participants received single dose of MNTX 0.15 mg/kg SC initially. Subsequent dosing was adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability. Median treatment duration was 25 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Bausch Health Companies | Lindsey.Mathew@bauschhealth.com |
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| 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 |
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| ID | Term |
|---|---|
| C032257 | methylnaltrexone |
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| Death |
|
| Unresponsive to treatment |
|
| Other |
|
| Other than specified |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| 11 |
| 25 |
| 15 |
| 25 |
| Myocardial infarction | Cardiac disorders | MedDRA v11.0 | Systematic Assessment |
|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v11.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA v11.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA v11.0 | Systematic Assessment |
|
| Hepatic failure | Hepatobiliary disorders | MedDRA v11.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Dizziness | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
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| Myoclonus | Nervous system disorders | MedDRA v11.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
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| Bronchitis bacterial | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
|
| Abdominal distension | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA v11.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA v11.0 | Systematic Assessment |
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| Restlessness | Psychiatric disorders | MedDRA v11.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA v11.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA v11.0 | Systematic Assessment |
|
| Oedema peripheral | Psychiatric disorders | MedDRA v11.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA v11.0 | Systematic Assessment |
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| Hallucination, visual | Psychiatric disorders | MedDRA v11.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
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| Faecaloma | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v11.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
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| Sedation | Infections and infestations | MedDRA v11.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA v11.0 | Systematic Assessment |
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| Bladder spasm | Renal and urinary disorders | MedDRA v11.0 | Systematic Assessment |
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| Urinary hesitation | Renal and urinary disorders | MedDRA v11.0 | Systematic Assessment |
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| Nocturia | Renal and urinary disorders | MedDRA v11.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA v11.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA v11.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Increased bronchial secretion | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Sputum retention | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v11.0 | Systematic Assessment |
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| Lacrimation increased | Eye disorders | MedDRA v11.0 | Systematic Assessment |
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| Catheter related complication | General disorders | MedDRA v11.0 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA v11.0 | Systematic Assessment |
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| Secretion discharge | General disorders | MedDRA v11.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA v11.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA v11.0 | Systematic Assessment |
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| Feeling abnormal | General disorders | MedDRA v11.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA v11.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA v11.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v11.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA v11.0 | Systematic Assessment |
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| Arthralgia | Metabolism and nutrition disorders | MedDRA v11.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA v11.0 | Systematic Assessment |
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| Oral intake reduced | Metabolism and nutrition disorders | MedDRA v11.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Bursa disorder | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v11.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA v11.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v11.0 | Systematic Assessment |
|
| Endotracheal intubation complication | Injury, poisoning and procedural complications | MedDRA v11.0 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MedDRA v11.0 | Systematic Assessment |
|
| Creatinine renal clearance decreased | Investigations | MedDRA v11.0 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA v11.0 | Systematic Assessment |
|
| Blood magnesium decreased | Investigations | MedDRA v11.0 | Systematic Assessment |
|
| Cyanosis | Cardiac disorders | MedDRA v11.0 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA v11.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA v11.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA v11.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA v11.0 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA v11.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA v11.0 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA v11.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA v11.0 | Systematic Assessment |
|
Please contact Sponsor directly for additional information.
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |