Trial Outcomes & Findings for Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain (NCT NCT00547586)
NCT ID: NCT00547586
Last Updated: 2020-08-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
6 hours
Results posted on
2020-08-20
Participant Flow
Participant milestones
| Measure |
Placebo
placebo: placebo
|
150 mg
N-methylnaltrexone bromide (MOA-728): Oral
|
300 mg
N-methylnaltrexone bromide (MOA-728): Oral
|
450 mg
N-methylnaltrexone bromide (MOA-728): Oral
|
600 mg
N-methylnaltrexone bromide (MOA-728): Oral
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
7
|
14
|
33
|
35
|
|
Overall Study
COMPLETED
|
28
|
6
|
13
|
27
|
32
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
1
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain
Baseline characteristics by cohort
| Measure |
Placebo
n=33 Participants
placebo: placebo
|
150 mg
n=7 Participants
N-methylnaltrexone bromide (MOA-728): Oral
|
300 mg
n=14 Participants
N-methylnaltrexone bromide (MOA-728): Oral
|
450 mg
n=33 Participants
N-methylnaltrexone bromide (MOA-728): Oral
|
600 mg
n=35 Participants
N-methylnaltrexone bromide (MOA-728): Oral
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
48.43 years
STANDARD_DEVIATION 6.80 • n=7 Participants
|
52.43 years
STANDARD_DEVIATION 8.56 • n=5 Participants
|
51.21 years
STANDARD_DEVIATION 12.24 • n=4 Participants
|
49.51 years
STANDARD_DEVIATION 11.25 • n=21 Participants
|
49.84 years
STANDARD_DEVIATION 10.39 • n=10 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
74 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
48 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 6 hoursOutcome measures
| Measure |
Placebo
n=33 Participants
placebo: placebo
|
150 mg
n=7 Participants
N-methylnaltrexone bromide (MOA-728): Oral
|
300 mg
n=14 Participants
N-methylnaltrexone bromide (MOA-728): Oral
|
450 mg
n=33 Participants
N-methylnaltrexone bromide (MOA-728): Oral
|
600 mg
n=35 Participants
N-methylnaltrexone bromide (MOA-728): Oral
|
|---|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
7 Participants
|
2 Participants
|
|
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
|
1 Participants
|
1 Participants
|
9 Participants
|
5 Participants
|
|
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
|
1 Participants
|
2 Participants
|
13 Participants
|
9 Participants
|
|
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
|
1 Participants
|
4 Participants
|
15 Participants
|
14 Participants
|
|
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
|
1 Participants
|
4 Participants
|
15 Participants
|
17 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 15 deaths
150 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths
300 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 4 deaths
450 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 13 deaths
600 mg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Placebo
n=33 participants at risk
placebo: placebo
|
150 mg
n=7 participants at risk
N-methylnaltrexone bromide (MOA-728): Oral
|
300 mg
n=14 participants at risk
N-methylnaltrexone bromide (MOA-728): Oral
|
450 mg
n=33 participants at risk
N-methylnaltrexone bromide (MOA-728): Oral
|
600 mg
n=35 participants at risk
N-methylnaltrexone bromide (MOA-728): Oral
|
|---|---|---|---|---|---|
|
General disorders
Lymphedema
|
0.00%
0/33 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
0.00%
0/14 • 6 weeks
|
0.00%
0/33 • 6 weeks
|
2.9%
1/35 • 6 weeks
|
|
General disorders
Pain
|
0.00%
0/33 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
0.00%
0/14 • 6 weeks
|
0.00%
0/33 • 6 weeks
|
2.9%
1/35 • 6 weeks
|
|
Infections and infestations
Cellulitis staphyloccocal
|
0.00%
0/33 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
0.00%
0/14 • 6 weeks
|
0.00%
0/33 • 6 weeks
|
2.9%
1/35 • 6 weeks
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/33 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
0.00%
0/14 • 6 weeks
|
0.00%
0/33 • 6 weeks
|
2.9%
1/35 • 6 weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/33 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
0.00%
0/14 • 6 weeks
|
0.00%
0/33 • 6 weeks
|
2.9%
1/35 • 6 weeks
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/33 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
0.00%
0/14 • 6 weeks
|
0.00%
0/33 • 6 weeks
|
2.9%
1/35 • 6 weeks
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/33 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
0.00%
0/14 • 6 weeks
|
3.0%
1/33 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
Other adverse events
| Measure |
Placebo
n=33 participants at risk
placebo: placebo
|
150 mg
n=7 participants at risk
N-methylnaltrexone bromide (MOA-728): Oral
|
300 mg
n=14 participants at risk
N-methylnaltrexone bromide (MOA-728): Oral
|
450 mg
n=33 participants at risk
N-methylnaltrexone bromide (MOA-728): Oral
|
600 mg
n=35 participants at risk
N-methylnaltrexone bromide (MOA-728): Oral
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/33 • 6 weeks
|
14.3%
1/7 • 6 weeks
|
0.00%
0/14 • 6 weeks
|
0.00%
0/33 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
|
Gastrointestinal disorders
Abdominal distention
|
6.1%
2/33 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
0.00%
0/14 • 6 weeks
|
6.1%
2/33 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/33 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
14.3%
2/14 • 6 weeks
|
6.1%
2/33 • 6 weeks
|
2.9%
1/35 • 6 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/33 • 6 weeks
|
14.3%
1/7 • 6 weeks
|
0.00%
0/14 • 6 weeks
|
6.1%
2/33 • 6 weeks
|
5.7%
2/35 • 6 weeks
|
|
Gastrointestinal disorders
Flatulence
|
6.1%
2/33 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
7.1%
1/14 • 6 weeks
|
0.00%
0/33 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/33 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
7.1%
1/14 • 6 weeks
|
0.00%
0/33 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
9.1%
3/33 • 6 weeks
|
14.3%
1/7 • 6 weeks
|
7.1%
1/14 • 6 weeks
|
3.0%
1/33 • 6 weeks
|
2.9%
1/35 • 6 weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
1/33 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
0.00%
0/14 • 6 weeks
|
6.1%
2/33 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/33 • 6 weeks
|
14.3%
1/7 • 6 weeks
|
0.00%
0/14 • 6 weeks
|
0.00%
0/33 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
|
Infections and infestations
Influenza
|
6.1%
2/33 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
0.00%
0/14 • 6 weeks
|
0.00%
0/33 • 6 weeks
|
2.9%
1/35 • 6 weeks
|
|
Infections and infestations
Urinary tract infection
|
3.0%
1/33 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
7.1%
1/14 • 6 weeks
|
0.00%
0/33 • 6 weeks
|
2.9%
1/35 • 6 weeks
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/33 • 6 weeks
|
14.3%
1/7 • 6 weeks
|
0.00%
0/14 • 6 weeks
|
0.00%
0/33 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/33 • 6 weeks
|
14.3%
1/7 • 6 weeks
|
0.00%
0/14 • 6 weeks
|
0.00%
0/33 • 6 weeks
|
0.00%
0/35 • 6 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/33 • 6 weeks
|
0.00%
0/7 • 6 weeks
|
7.1%
1/14 • 6 weeks
|
0.00%
0/33 • 6 weeks
|
2.9%
1/35 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor directly for details.
- Publication restrictions are in place
Restriction type: OTHER