Constipation
Conditions
Brief summary
The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).
Interventions
OTHERplacebo
placebo
Sponsors
Progenics Pharmaceuticals, Inc.
Bausch Health Americas, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer. * Taking oral, transdermal, intravenous, or subcutaneous opioids. * Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.
Exclusion criteria
* History of chronic constipation before the initiation of opioid therapy. * Other GI disorders known to affect bowel transit. * Women who are pregnant, breast-feeding, or plan to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | 6 hours |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo placebo: placebo | 33 |
| 150 mg N-methylnaltrexone bromide (MOA-728): Oral | 7 |
| 300 mg N-methylnaltrexone bromide (MOA-728): Oral | 14 |
| 450 mg N-methylnaltrexone bromide (MOA-728): Oral | 33 |
| 600 mg N-methylnaltrexone bromide (MOA-728): Oral | 35 |
| Total | 122 |
Baseline characteristics
| Characteristic | Placebo | 150 mg | 300 mg | 450 mg | 600 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 8.75 | 48.43 years STANDARD_DEVIATION 6.8 | 52.43 years STANDARD_DEVIATION 8.56 | 51.21 years STANDARD_DEVIATION 12.24 | 49.51 years STANDARD_DEVIATION 11.25 | 49.84 years STANDARD_DEVIATION 10.39 |
| Sex: Female, Male Female | 22 Participants | 5 Participants | 5 Participants | 24 Participants | 18 Participants | 74 Participants |
| Sex: Female, Male Male | 11 Participants | 2 Participants | 9 Participants | 9 Participants | 17 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 15 / 33 | 3 / 7 | 4 / 14 | 13 / 33 | 18 / 35 |
| other Total, other adverse events | 10 / 33 | 3 / 7 | 4 / 14 | 9 / 33 | 6 / 35 |
| serious Total, serious adverse events | 0 / 33 | 0 / 7 | 0 / 14 | 1 / 33 | 3 / 35 |
Outcome results
Primary
Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment
Time frame: 6 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 6 hours of 1st dose | 6 Participants |
| Placebo | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 2 hours of 1st dose | 1 Participants |
| Placebo | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 4 hours of 1st dose | 3 Participants |
| Placebo | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 3 hours of 1st dose | 3 Participants |
| Placebo | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 1 hour of 1st dose | 0 Participants |
| 150 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 2 hours of 1st dose | 1 Participants |
| 150 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 4 hours of 1st dose | 1 Participants |
| 150 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 1 hour of 1st dose | 0 Participants |
| 150 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 6 hours of 1st dose | 1 Participants |
| 150 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 3 hours of 1st dose | 1 Participants |
| 300 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 3 hours of 1st dose | 2 Participants |
| 300 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 4 hours of 1st dose | 4 Participants |
| 300 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 6 hours of 1st dose | 4 Participants |
| 300 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 2 hours of 1st dose | 1 Participants |
| 300 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 1 hour of 1st dose | 0 Participants |
| 450 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 6 hours of 1st dose | 15 Participants |
| 450 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 1 hour of 1st dose | 7 Participants |
| 450 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 2 hours of 1st dose | 9 Participants |
| 450 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 3 hours of 1st dose | 13 Participants |
| 450 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 4 hours of 1st dose | 15 Participants |
| 600 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 4 hours of 1st dose | 14 Participants |
| 600 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 3 hours of 1st dose | 9 Participants |
| 600 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 2 hours of 1st dose | 5 Participants |
| 600 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 1 hour of 1st dose | 2 Participants |
| 600 mg | Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment | Within 6 hours of 1st dose | 17 Participants |