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| ID | Type | Description | Link |
|---|---|---|---|
| B2541004 |
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| Name | Class |
|---|---|
| Progenics Pharmaceuticals, Inc. | INDUSTRY |
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The primary purpose of this study is to evaluate the safety, efficacy, and tolerability of subcutaneous (injection beneath the skin) MOA-728 versus placebo in adult Asian subjects with opioid-induced constipation associated with advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease) or chronic nonmalignant pain.
Subjects received subcutaneous methylnaltrexone (also referred to as MOA-728 or MNTX) or placebo every other day beginning on Day 1 up to a maximum of 7 doses during the 2-week double-blind period.
Inclusion criteria for this study included subjects with advanced illness or subjects with chronic nonmalignant pain. The actual study population included only subjects with cancer-related advanced illness.
All subjects who completed the double-blind treatment phase of this study could elect to receive methylnaltrexone during a 12-week open-label extension study, provided eligibility criteria were met. Subjects who did not continue in the open-label extension study had a follow-up visit 2 weeks after their last dose of test article.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylnaltrexone double-blind | Experimental | Methylnaltrexone once every other day. |
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| Placebo | Placebo Comparator | Placebo once every other day. |
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| Methylnaltrexone open-label | Other | Subjects who completed the double-blind period had the option to receive methylnaltrexone once every other day during a 12-week, open-label extension period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylnaltrexone | Drug | Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and < 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and <38 kg. Study duration: 2 weeks double-blind period (MNTX treatments) followed by 12 weeks open-label extension period (MNTX treatments). |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Subjects Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours After the First Injection. | There were 2 co-primary endpoints for this study. This measurement is the first of the 2 co-primary endpoints. This endpoint measures the percentage of patients who had an RFBM within 4 hours after the first dose of test article during the double-blind period; data are expressed as percentages of patients for the MNTX and placebo groups. To qualify as rescue free, the bowel movement could not occur within 6 hours after a rectal intervention (ie, rectal suppository, enema, manual disimpaction). Note that efficacy results (primary and secondary outcomes) are presented for the double-blind period only. Therefore, no efficacy results are presented for the open-label period. | Up to 4 hours after the first injection |
| The Proportion of Subjects Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours After Each Dose During Double-blind Period. | This measurement is the second of the 2 co-primary endpoints. This endpoint measures the percentage of patients who had an RFBM within 4 hours after each dose of test article during the double-blind period; data are expressed as percentages of patients by dose (first, second, third, fourth, etc.) for the MNTX and placebo groups. The definition of RFBM is described above (see first co-primary endpoint). | Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Injections Resulting in RFBM Within 4 Hours After Test Article Administration. | This endpoint measures the percentage of injections resulting in RFBMs within 4 hours after test article administration during the double-blind period. The percentage of injections resulting in RFBMs is calculated for each patient and then data are expressed as the mean (± standard deviation) percentage for the MNTX and placebo groups. The definition of RFBM is described above (see first co-primary endpoint). |
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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 |
|---|---|---|---|---|---|---|
| Koyang-shi | Kyounggi-do | 410-719 | South Korea | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylnaltrexone Double-blind | Methylnaltrexone once every other day. |
| FG001 | Placebo | Placebo once every other day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind |
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| Placebo | Drug | Subjects received matching placebo injections. Study duration: 2 weeks double-blind period (placebo treatments) followed by 12 weeks open-label extension period (MNTX treatments). |
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| Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period |
| Seoul |
| 135-710 |
| South Korea |
| Seoul | 137-701 | South Korea |
| Seoul | 152-703 | South Korea |
| Tainan | 70428 | Taiwan |
| Taipei TOC | 100 | Taiwan |
| FG002 | Methylnaltrexone Open-label | Subjects who completed the double-blind period had the option to receive methylnaltrexone once every other day during a 12-week, open-label extension period. |
| COMPLETED |
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| NOT COMPLETED |
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| Open-label |
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All randomized subjects were included in the baseline population. Patients in the MNTX open-label group included subjects who had already participated in the MNTX double-blind or placebo groups during the double-blind period. Therefore, baseline characteristics are not repeated for the subjects who continued in the open-label extension period.
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylnaltrexone Double-blind | Methylnaltrexone once every other day. Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and < 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and <38 kg. |
| BG001 | Placebo | Placebo once every other day. Subjects received matching placebo injections. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Eastern Cooperative Oncology Group Score | Count of Participants | Participants |
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| Hospitalization Status at Screening Period | Number | participants |
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| Underlying Advanced Illness - Cancer-related illness | Count of Participants | Participants |
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| Weight | Count of Participants | 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 Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours After the First Injection. | There were 2 co-primary endpoints for this study. This measurement is the first of the 2 co-primary endpoints. This endpoint measures the percentage of patients who had an RFBM within 4 hours after the first dose of test article during the double-blind period; data are expressed as percentages of patients for the MNTX and placebo groups. To qualify as rescue free, the bowel movement could not occur within 6 hours after a rectal intervention (ie, rectal suppository, enema, manual disimpaction). Note that efficacy results (primary and secondary outcomes) are presented for the double-blind period only. Therefore, no efficacy results are presented for the open-label period. | Although 25 patients in the MNTX group and 24 in the placebo group received study drug, 24 and 23 patients, respectively, had ≥ 1 post baseline diary assessment and were analyzed for efficacy. | Posted | Number | percentage of participants | Up to 4 hours after the first injection |
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| Secondary | Percentage of Injections Resulting in RFBM Within 4 Hours After Test Article Administration. | This endpoint measures the percentage of injections resulting in RFBMs within 4 hours after test article administration during the double-blind period. The percentage of injections resulting in RFBMs is calculated for each patient and then data are expressed as the mean (± standard deviation) percentage for the MNTX and placebo groups. The definition of RFBM is described above (see first co-primary endpoint). | Although 25 patients in the MNTX group and 24 in the placebo group received study drug, 24 and 23 patients, respectively, had ≥ 1 post baseline diary assessment and were analyzed for efficacy. | Posted | Mean | Standard Deviation | percentage of injections | Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period |
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| Primary | The Proportion of Subjects Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours After Each Dose During Double-blind Period. | This measurement is the second of the 2 co-primary endpoints. This endpoint measures the percentage of patients who had an RFBM within 4 hours after each dose of test article during the double-blind period; data are expressed as percentages of patients by dose (first, second, third, fourth, etc.) for the MNTX and placebo groups. The definition of RFBM is described above (see first co-primary endpoint). | Although 25 patients in the MNTX group and 24 in the placebo group received study drug, 24 and 23 patients, respectively, had ≥ 1 post baseline diary assessment and were analyzed for efficacy. | Posted | Number | percentage of participants | Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period |
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Adverse events were collected over the 2-week double-blind period and over the 12-week open-label 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 Double-blind | Methylnaltrexone once every other day. Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and < 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and <38 kg. | 12 | 25 | 16 | 25 | ||
| EG001 | Placebo | Placebo once every other day. Subjects received matching placebo injections. | 8 | 24 | 18 | 24 | ||
| EG002 | Methylnaltrexone Open-label | Subjects who completed the double-blind period had the option to receive methylnaltrexone once every other day during a 12-week, open-label extension period. | 21 | 31 | 25 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Disease progression | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
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| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
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| Dysuria | Renal and urinary 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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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Malignant neoplasm progression | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
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| Mesothelioma malignant advanced | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
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| Diplegia | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
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| Hepatic encephalopathy | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Melena | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Feeling cold | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Hepatic failure | Hepatobiliary 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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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
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| Metastatic gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
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| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Sputum increased | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (14.0) | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Asthenia | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Edema | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Edema peripheral | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA (14.0) | Systematic Assessment |
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| Jaundice | Hepatobiliary disorders | MedDRA (14.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (14.0) | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.0) | Systematic Assessment |
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| Hypoalbuminemia | 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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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (14.0) | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA (14.0) | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (14.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal 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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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (14.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Sorscher | Salix Pharmaceuticals | 919-862-1827 | david.sorscher@salix.com |
| ID | Term |
|---|---|
| D003248 | Constipation |
| D000079689 | Opioid-Induced Constipation |
| ID | Term |
|---|---|
| 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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| 1 - Restricted in strenuous activity |
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| 2 - Unable to work |
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| 3 - Limited self-care |
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| No |
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| 38 - < 62 kg |
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| ≥62 kg |
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| Missing |
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| Units | Counts |
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| Participants |
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