Trial Outcomes & Findings for Methylnaltrexone for Opioid-induced Constipation in Cancer Patients (NCT NCT01004393)
NCT ID: NCT01004393
Last Updated: 2016-02-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
4 hours after the dose of subcutaneous methylnaltrexone
Results posted on
2016-02-02
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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12
|
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Overall Study
COMPLETED
|
12
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Methylnaltrexone for Opioid-induced Constipation in Cancer Patients
Baseline characteristics by cohort
| Measure |
Methylnaltrexone
n=12 Participants
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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|---|---|
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Age, Continuous
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52 years
n=99 Participants
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Sex: Female, Male
Female
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7 Participants
n=99 Participants
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Sex: Female, Male
Male
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5 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: 4 hours after the dose of subcutaneous methylnaltrexoneOutcome measures
| Measure |
Methylnaltrexone
n=12 Participants
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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|---|---|
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Rescue-free Laxation After Administration of Subcutaneous Methylnaltrexone
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33 percentage of participants
Interval 9.9 to 65.0
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SECONDARY outcome
Timeframe: 24 and 48 hours after the dose of subcutaneous methylnaltrexoneOutcome measures
| Measure |
Methylnaltrexone
n=12 Participants
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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|---|---|
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Laxation After Administration of Subcutaneous Methylnaltrexone
Rescue-free Laxation within 24 hours (n=12)
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42 percentage of participants
Interval 15.0 to 72.0
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Laxation After Administration of Subcutaneous Methylnaltrexone
Laxation within 48 hours (n=12)
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83 percentage of participants
Interval 52.0 to 98.0
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SECONDARY outcome
Timeframe: 48 hours after the dose of subcutaneous methylnaltrexoneOutcome measures
| Measure |
Methylnaltrexone
n=12 Participants
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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|---|---|
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Time to Laxation After Administration of Subcutaneous Methylnaltrexone
Mean time to rescue-free laxation ≤4 hours (n=11)
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3.3 hours
Standard Error 0.134
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Time to Laxation After Administration of Subcutaneous Methylnaltrexone
Mean time to rescue-free laxation ≤24 hours (n=11)
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16 hours
Standard Error 0.155
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Time to Laxation After Administration of Subcutaneous Methylnaltrexone
Mean time to laxation ≤48 hours (n=11)
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20 hours
Standard Error 0.087
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SECONDARY outcome
Timeframe: 48 hours after the dose of subcutaneous methylnaltrexoneOutcome measures
| Measure |
Methylnaltrexone
n=12 Participants
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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|---|---|
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Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone
Average pain (0-4 hours) (n=12)
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2.9 units on a scale
Standard Deviation 2.7
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Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone
Average pain (4-24 hours) (n=12)
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2.4 units on a scale
Standard Deviation 3.0
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Overall Pain Scores (0-10; 0=no Pain, 10=Worst Pain) After Administration of Subcutaneous Methylnaltrexone
Average pain (24-48 hours) (n=12)
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2.3 units on a scale
Standard Deviation 3.1
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SECONDARY outcome
Timeframe: 48 hours after the dose of subcutaneous methylnaltrexoneOutcome measures
| Measure |
Methylnaltrexone
n=12 Participants
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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|---|---|
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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
0-4 hours (n=12)
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8.8 units on a scale
Standard Deviation 1.1
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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
4-24 hours (n=12)
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9.2 units on a scale
Standard Deviation 2.2
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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
24-48 hours (n=11)
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8.8 units on a scale
Standard Deviation 1.8
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SECONDARY outcome
Timeframe: 48 hours after the dose of subcutaneous methylnaltrexoneOutcome measures
| Measure |
Methylnaltrexone
n=12 Participants
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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|---|---|
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Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone
Frequency of ≥ 1 laxation (0-4 hours) (n=12)
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33 percentage of participants
Interval 9.9 to 65.0
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Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone
Frequency of ≥ 1 laxation (4-24 hours) (n=12)
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42 percentage of participants
Interval 19.0 to 68.0
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Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone
Frequency of ≥ 1 laxation (24-48 hours) (n=11)
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73 percentage of participants
Interval 43.0 to 90.0
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Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone
Consistency (slight-very hard) (0-4 hours) (n=12)
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8 percentage of participants
Interval 1.0 to 36.0
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Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone
Consistency (slight-very hard) (4-24 hours) (n=12)
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8 percentage of participants
Interval 1.0 to 36.0
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Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone
Consistency (slight-very hard)(24-48 hours) (n=11)
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9 percentage of participants
Interval 2.0 to 38.0
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Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone
Difficulty (severe-very severe) (0-4 hours) (n=12)
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42 percentage of participants
Interval 19.0 to 68.0
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Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone
Difficulty (severe-very severe)(4-24 hours) (n=12)
|
42 percentage of participants
Interval 19.0 to 68.0
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Bowel Movement Assessment (Frequency, Consistency and Difficulty) After Administration of Subcutaneous Methylnaltrexone
Difficulty (severe-very severe)(24-48hours) (n=11)
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18 percentage of participants
Interval 5.0 to 48.0
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SECONDARY outcome
Timeframe: 48 hours after the dose of subcutaneous methylnaltrexoneOutcome measures
| Measure |
Methylnaltrexone
n=12 Participants
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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|---|---|
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Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone
Severity (severe-very severe) (0-4 hours) (n=12)
|
42 percentage of participants
Interval 19.0 to 68.0
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Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone
Severity (severe-very severe) (4-24 hours) (n=12)
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50 percentage of participants
Interval 25.0 to 75.0
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Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone
Severity (severe-very severe) (24-48 hours) (n=11)
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27 percentage of participants
Interval 10.0 to 57.0
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Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone
Distress (severe-very severe) (0-4 hours) (n=12)
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25 percentage of participants
Interval 9.0 to 54.0
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Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone
Distress (severe-very severe) (4-24 hours) (n=12)
|
25 percentage of participants
Interval 9.0 to 54.0
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Constipation Assessment (Severity and Distress) After Administration of Subcutaneous Methylnaltrexone
Distress (severe-very severe) (24-48 hours) (n=11)
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0 percentage of participants
Interval 0.0 to 26.0
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SECONDARY outcome
Timeframe: 48 hours after the dose of subcutaneous methylnaltrexoneOutcome measures
| Measure |
Methylnaltrexone
n=12 Participants
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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|---|---|
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Patient Satisfaction With the Study Medication After Administration of Subcutaneous Methylnaltrexone
Satisfied-very satisfied (0-4 hours) (n=12)
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33 percentage of participants
Interval 14.0 to 61.0
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Patient Satisfaction With the Study Medication After Administration of Subcutaneous Methylnaltrexone
Satisfied-very satisfied (4-24 hours) (n=12)
|
58 percentage of participants
Interval 32.0 to 81.0
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Patient Satisfaction With the Study Medication After Administration of Subcutaneous Methylnaltrexone
Satisfied-very satisfied (24-48 hours) (n=11)
|
64 percentage of participants
Interval 35.0 to 85.0
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Adverse Events
Methylnaltrexone
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Methylnaltrexone
n=12 participants at risk
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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|---|---|
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Gastrointestinal disorders
Abdominal pain
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66.7%
8/12 • 4 years and 2 months
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Gastrointestinal disorders
Flatulence
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83.3%
10/12 • 4 years and 2 months
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Gastrointestinal disorders
Nausea
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75.0%
9/12 • 4 years and 2 months
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Nervous system disorders
Dizziness
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33.3%
4/12 • 4 years and 2 months
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General disorders
Diaphoresis
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58.3%
7/12 • 4 years and 2 months
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Gastrointestinal disorders
Diarrhea
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25.0%
3/12 • 4 years and 2 months
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Skin and subcutaneous tissue disorders
Injection site reaction
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0.00%
0/12 • 4 years and 2 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place