Trial Outcomes & Findings for Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain (NCT NCT00605644)
NCT ID: NCT00605644
Last Updated: 2020-08-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
128 participants
Primary outcome timeframe
3 hours
Results posted on
2020-08-20
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo
Placebo: Placebo
|
150 mg
MOA-728
MOA-728: Oral Capsules
|
300 mg
MOA-728
MOA-728: Oral Capsules
|
450 mg
MOA-728
MOA-728: Oral Capsules
|
600 mg
MOA-728
MOA-728: Oral Capsules
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
19
|
20
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
18
|
18
|
25
|
22
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain
Baseline characteristics by cohort
| Measure |
Placebo
n=29 Participants
Placebo
Placebo: Placebo
|
150 mg
n=19 Participants
MOA-728
MOA-728: Oral Capsules
|
300 mg
n=20 Participants
MOA-728
MOA-728: Oral Capsules
|
450 mg
n=30 Participants
MOA-728
MOA-728: Oral Capsules
|
600 mg
n=30 Participants
MOA-728
MOA-728: Oral Capsules
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
54.24 years
STANDARD_DEVIATION 10.45 • n=93 Participants
|
54.68 years
STANDARD_DEVIATION 9.49 • n=4 Participants
|
51.25 years
STANDARD_DEVIATION 12.72 • n=27 Participants
|
50.17 years
STANDARD_DEVIATION 10.46 • n=483 Participants
|
49.13 years
STANDARD_DEVIATION 8.59 • n=36 Participants
|
51.69 years
STANDARD_DEVIATION 10.38 • n=10 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
22 Participants
n=36 Participants
|
77 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
51 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: 3 hoursOutcome measures
| Measure |
Placebo
n=29 Participants
Placebo
Placebo: Placebo
|
150 mg
n=19 Participants
MOA-728
MOA-728: Oral Capsules
|
300 mg
n=20 Participants
MOA-728
MOA-728: Oral Capsules
|
450 mg
n=30 Participants
MOA-728
MOA-728: Oral Capsules
|
600 mg
n=30 Participants
MOA-728
MOA-728: Oral Capsules
|
|---|---|---|---|---|---|
|
Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment
|
2 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
150 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
300 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
450 mg
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
600 mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=29 participants at risk
Placebo
Placebo: Placebo
|
150 mg
n=19 participants at risk
MOA-728
MOA-728: Oral Capsules
|
300 mg
n=20 participants at risk
MOA-728
MOA-728: Oral Capsules
|
450 mg
n=30 participants at risk
MOA-728
MOA-728: Oral Capsules
|
600 mg
n=30 participants at risk
MOA-728
MOA-728: Oral Capsules
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
0.00%
0/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
3.3%
1/30 • 4 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
0.00%
0/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
3.3%
1/30 • 4 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
0.00%
0/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
3.3%
1/30 • 4 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
0.00%
0/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
3.3%
1/30 • 4 weeks
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
0.00%
0/20 • 4 weeks
|
3.3%
1/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
Other adverse events
| Measure |
Placebo
n=29 participants at risk
Placebo
Placebo: Placebo
|
150 mg
n=19 participants at risk
MOA-728
MOA-728: Oral Capsules
|
300 mg
n=20 participants at risk
MOA-728
MOA-728: Oral Capsules
|
450 mg
n=30 participants at risk
MOA-728
MOA-728: Oral Capsules
|
600 mg
n=30 participants at risk
MOA-728
MOA-728: Oral Capsules
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
1/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
0.00%
0/20 • 4 weeks
|
13.3%
4/30 • 4 weeks
|
6.7%
2/30 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
3.3%
1/30 • 4 weeks
|
3.3%
1/30 • 4 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
3.3%
1/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
|
Gastrointestinal disorders
Haemorrhoid
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29 • 4 weeks
|
5.3%
1/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
6.7%
2/30 • 4 weeks
|
6.7%
2/30 • 4 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29 • 4 weeks
|
5.3%
1/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
6.7%
2/30 • 4 weeks
|
3.3%
1/30 • 4 weeks
|
|
Gastrointestinal disorders
Pyrexia
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
|
Investigations
Band neutrophil count increased
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
|
Investigations
White blood cell count increased
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
|
Metabolism and nutrition disorders
Food craving
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.9%
2/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
0.00%
0/20 • 4 weeks
|
3.3%
1/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
|
Musculoskeletal and connective tissue disorders
Nuchal rigidity
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • 4 weeks
|
5.3%
1/19 • 4 weeks
|
0.00%
0/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
|
Nervous system disorders
Headache
|
3.4%
1/29 • 4 weeks
|
10.5%
2/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/29 • 4 weeks
|
5.3%
1/19 • 4 weeks
|
0.00%
0/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
0.00%
0/30 • 4 weeks
|
|
Vascular disorders
Orthostatic hypertension
|
0.00%
0/29 • 4 weeks
|
0.00%
0/19 • 4 weeks
|
5.0%
1/20 • 4 weeks
|
3.3%
1/30 • 4 weeks
|
0.00%
0/30 • 4 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