Opioid-induced Constipation
Conditions
Brief summary
This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation.
Interventions
DRUGMethylnaltrexone
Methylnaltrexone will be administered as per the dose and schedule specified in the arm.
Sponsors
Bausch Health Americas, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced medical illness (that is; terminal illness, such as incurable cancer or end stage aqcuired immunodeficiency syndrome \[AIDS\]) with a life expectancy of one to six months. * On an opioid regimen for the control of pain/discomfort for at least seven days. * Has opioid-induced constipation. * Stable vital signs and systolic blood pressure greater than or equal to (\>=) 85 millimeters of mercury (mmHg), and diastolic blood pressure \>=45 mmHg (Supine or sitting). * Females of childbearing potential must have a negative pregnancy test (serum or urine). * On a laxative regimen (for example, stool softener and SENNA or equivalent) for at least 3 days prior to treatment. Participants who have discontinued laxatives due to intolerability or lack of efficacy are also eligible.
Exclusion criteria
* Participants with known hypersensitivity to methylnaltrexone, naltrexone or naloxone. * Participants who received any investigational new drug (experimental) except for methylnaltrexone in the previous 30 days. * Participants who are constipated with a disease process suggestive of gastrointestinal obstruction, impaction or diagnosed with a current abdominal pathologic process which may represent a non-opioid cause of bowel dysfunction. * Participants who are constipated and have active, clinically significant diverticulitis. * Participants with a surgically acute abdomen. * Participants being treated with opioids for diarrhea, dyspnea, cough, pulmonary edema, or congestive heart failure. * Individuals with a known drug addiction. * Females who are pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Opioid Induced Side Effects | From start of treatment until end of study (up to maximum 3.4 years) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 6 |
| Overall Study | Disease progression | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other | 3 |
| Overall Study | Other than specified | 2 |
| Overall Study | Unresponsive to treatment | 5 |
Baseline characteristics
| Characteristic | Methylnaltrexone |
|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 13.63 |
| Race/Ethnicity, Customized Caucasian | 24 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 25 |
| serious Total, serious adverse events | 11 / 25 |
Outcome results
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.
Time frame: From start of treatment until end of study (up to maximum 3.4 years)
Population: All enrolled participants who provided a signed and dated written ICF.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Methylnaltrexone | Number of Participants With Opioid Induced Side Effects | Nausea | 3 Participants |
| Methylnaltrexone | Number of Participants With Opioid Induced Side Effects | Myoclonus | 1 Participants |
| Methylnaltrexone | Number of Participants With Opioid Induced Side Effects | Vomiting | 3 Participants |
| Methylnaltrexone | Number of Participants With Opioid Induced Side Effects | Sedation | 1 Participants |
| Methylnaltrexone | Number of Participants With Opioid Induced Side Effects | Constipation | 1 Participants |
| Methylnaltrexone | Number of Participants With Opioid Induced Side Effects | Urinary retention | 3 Participants |
| Methylnaltrexone | Number of Participants With Opioid Induced Side Effects | Mental clouding | 4 Participants |
| Methylnaltrexone | Number of Participants With Opioid Induced Side Effects | Sweating | 2 Participants |
| Methylnaltrexone | Number of Participants With Opioid Induced Side Effects | Pruritus | 0 Participants |