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| ID | Type | Description | Link |
|---|---|---|---|
| VCC 0911 | Other Identifier | Vermont Cancer Center |
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The purpose of this study is to evaluate the efficacy of methylnaltrexone in relieving opioid-induced constipation in cancer patients at various stages of disease.
Pain is one of the most common and important symptoms of cancer, often requiring opioid analgesics for control. However constipation is one of the most frequent and debilitating side effects of opioids, occurring in 40%-70% of patients being treated for chronic pain. Although laxatives are commonly used to manage opioid-induced constipation, these agents are not always effective or satisfactory. Methylnaltrexone bromide is a peripherally acting antagonist of the mu-opioid receptor. As a quaternary amine, the ability of methylnaltrexone to cross the blood-brain barrier is limited. This allows methylnaltrexone to function as a peripherally-acting antagonist in the gastrointestinal tract without impacting opioid-mediated analgesic effects in the central nervous system. The efficacy and safety of methylnaltrexone in treating opioid-induced constipation in patients with advanced disease receiving palliative care has been demonstrated. However the efficacy of this agent has not been evaluated in more active patients who are earlier in their disease course. The present study will evaluate the efficacy and safety of methylnaltrexone for the relief of severe opioid-induced constipation in this population and will attempt to identify factors predictive of methylnaltrexone response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylnaltrexone bromide | Experimental | A single dose of methylnaltrexone will be administered subcutaneously to eligible subjects based on weight at the study entry. Since we will include subjects at all stages of cancer management, administering this study drug is considered experimental. We will use the dose approved by FDA, i.e., 0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylnaltrexone bromide | Drug | Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone | 4 hours after the dose of subcutaneous methylnaltrexone |
| Measure | Description | Time Frame |
|---|---|---|
| Laxation After Administration of Subcutaneous Methylnaltrexone | 24 and 48 hours after the dose of subcutaneous methylnaltrexone | |
| Time to Laxation After Administration of Subcutaneous Methylnaltrexone | 48 hours after the dose of subcutaneous methylnaltrexone |
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Inclusion Criteria:
Absolute neutrophil count > 1,500/microliter Hemoglobin > 7 g/dL Platelet count > 100,000/microliter Calculated calcium < 10.5 mg/dL Calculated creatinine clearance > 30 mg.min Alanine aminotransferase < 3 x upper limit of normal (ULN) Aspartate aminotransferase < 3 x ULN Alkaline phosphatase < 2.5 x ULN Bilirubin < 1.5 x ULN
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Ades, MD | Fletcher Allen Health Care / University of Vermont College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fletcher Allen Health Care | Burlington | Vermont | 05401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27628064 | Derived | Mori M, Ji Y, Kumar S, Ashikaga T, Ades S. Phase II trial of subcutaneous methylnaltrexone in the treatment of severe opioid-induced constipation (OIC) in cancer patients: an exploratory study. Int J Clin Oncol. 2017 Apr;22(2):397-404. doi: 10.1007/s10147-016-1041-6. Epub 2016 Sep 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylnaltrexone | Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylnaltrexone | Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone | Posted | Number | 95% Confidence Interval | percentage of participants | 4 hours after the dose of subcutaneous methylnaltrexone |
|
|
4 years and 2 months
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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 | Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Masanori Mori, MD | Seirei Hamamatsu General Hospital | 81-53-474-2222 | Masanori.Mori@sis.seirei.or.jp |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003248 | Constipation |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
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| ID | Term |
|---|---|
| C032257 | methylnaltrexone |
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|
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| Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone | 48 hours after the dose of subcutaneous methylnaltrexone |
| Symptoms of Opioid Withdrawal (Modified Himmelsbach Withdrawal Scales (Ranging 7-28 in Total; 1=None - 4=Severe for 7 Items)) After Administration of Subcutaneous Methylnaltrexone | 48 hours after the dose of subcutaneous methylnaltrexone |
| Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone | 48 hours after the dose of subcutaneous methylnaltrexone |
| Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone | 48 hours after the dose of subcutaneous methylnaltrexone |
| Patient Satisfaction With the Study Medication After Administration of Subcutaneous Methylnaltrexone | 48 hours after the dose of subcutaneous methylnaltrexone |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Laxation After Administration of Subcutaneous Methylnaltrexone | Posted | Number | 95% Confidence Interval | percentage of participants | 24 and 48 hours after the dose of subcutaneous methylnaltrexone |
|
|
|
| Secondary | Time to Laxation After Administration of Subcutaneous Methylnaltrexone | Posted | Mean | Standard Error | hours | 48 hours after the dose of subcutaneous methylnaltrexone |
|
|
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| Secondary | Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone | Posted | Mean | Standard Deviation | units on a scale | 48 hours after the dose of subcutaneous methylnaltrexone |
|
|
|
| Secondary | Symptoms of Opioid Withdrawal (Modified Himmelsbach Withdrawal Scales (Ranging 7-28 in Total; 1=None - 4=Severe for 7 Items)) After Administration of Subcutaneous Methylnaltrexone | Posted | Mean | Standard Deviation | units on a scale | 48 hours after the dose of subcutaneous methylnaltrexone |
|
|
|
| Secondary | Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone | Posted | Number | 95% Confidence Interval | percentage of participants | 48 hours after the dose of subcutaneous methylnaltrexone |
|
|
|
| Secondary | Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone | Posted | Number | 95% Confidence Interval | percentage of participants | 48 hours after the dose of subcutaneous methylnaltrexone |
|
|
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| Secondary | Patient Satisfaction With the Study Medication After Administration of Subcutaneous Methylnaltrexone | Posted | Number | 95% Confidence Interval | percentage of participants | 48 hours after the dose of subcutaneous methylnaltrexone |
|
|
|
|
| 0 |
| 12 |
| 12 |
| 12 |
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Diaphoresis | General disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Injection site reaction | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
|
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
|
|
| Consistency (slight-very hard) (0-4 hours) (n=12) |
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| Consistency (slight-very hard) (4-24 hours) (n=12) |
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| Consistency (slight-very hard)(24-48 hours) (n=11) |
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| Difficulty (severe-very severe) (0-4 hours) (n=12) |
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| Difficulty (severe-very severe)(4-24 hours) (n=12) |
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| Difficulty (severe-very severe)(24-48hours) (n=11) |
|
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| Distress (severe-very severe) (0-4 hours) (n=12) |
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| Distress (severe-very severe) (4-24 hours) (n=12) |
|
| Distress (severe-very severe) (24-48 hours) (n=11) |
|
| Title | Measurements |
|---|---|
|