Trial Outcomes & Findings for Asimadoline for the Treatment of Post-Operative Ileus (NCT NCT00443040)
NCT ID: NCT00443040
Last Updated: 2012-01-06
Results Overview
The time to first bowel movement or the time to tolerating solid food, whichever occurs later.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Daily for 38 days
Results posted on
2012-01-06
Participant Flow
Participant milestones
| Measure |
Asimadoline 1.0 mg
Asimadoline 1.0 mg b.i.d.
|
Asimadoline 3.0 mg
Asimadoline 3.0 mg b.i.d.
|
Placebo
Matching Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
10
|
|
Overall Study
COMPLETED
|
10
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
1
|
Reasons for withdrawal
| Measure |
Asimadoline 1.0 mg
Asimadoline 1.0 mg b.i.d.
|
Asimadoline 3.0 mg
Asimadoline 3.0 mg b.i.d.
|
Placebo
Matching Placebo
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Converted to an open laparotomy
|
3
|
0
|
1
|
Baseline Characteristics
Asimadoline for the Treatment of Post-Operative Ileus
Baseline characteristics by cohort
| Measure |
Asimadoline 1.0 mg
n=14 Participants
Asimadoline 1.0 mg b.i.d.
|
Asimadoline 3.0 mg
n=11 Participants
Asimadoline 3.0 mg b.i.d.
|
Placebo
n=10 Participants
Matching Placebo
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age Continuous
|
58 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
60 years
STANDARD_DEVIATION 12.9 • n=7 Participants
|
57 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
58 years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
35 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Daily for 38 daysPopulation: As the study was terminated early due to poor enrollment (31 of a planned 114 subjects were randomized and evaluable), no formal efficacy analyses were conducted.
The time to first bowel movement or the time to tolerating solid food, whichever occurs later.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 hours of ingesting a mealTime to tolerating solid food (toleration is defined as the absence of nausea or vomiting) within 4 hours of ingesting a meal
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily for 38 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily for 38 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily for 38 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily for 38 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily for 38 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily for 38 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily for 38 daysProportion of subjects with nasogastric tube re-insertion
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily for 38 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily for 38 daysAdverse events grouped by body system
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Daily for 38 daysChanges in laboratory values.
Outcome measures
Outcome data not reported
Adverse Events
Asimadoline 1.0 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Asimadoline 3.0 mg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Asimadoline 1.0 mg
n=14 participants at risk
Asimadoline 1.0 mg b.i.d.
|
Asimadoline 3.0 mg
n=11 participants at risk
Asimadoline 3.0 mg b.i.d.
|
Placebo
n=10 participants at risk
Matching Placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
bleeding gastric ulcer
|
0.00%
0/14
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
omental necrosis
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
Other adverse events
| Measure |
Asimadoline 1.0 mg
n=14 participants at risk
Asimadoline 1.0 mg b.i.d.
|
Asimadoline 3.0 mg
n=11 participants at risk
Asimadoline 3.0 mg b.i.d.
|
Placebo
n=10 participants at risk
Matching Placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
35.7%
5/14 • Number of events 5
|
63.6%
7/11 • Number of events 7
|
40.0%
4/10 • Number of events 4
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
28.6%
4/14 • Number of events 4
|
45.5%
5/11 • Number of events 5
|
60.0%
6/10 • Number of events 6
|
|
Gastrointestinal disorders
Abdominal Pain
|
42.9%
6/14 • Number of events 6
|
45.5%
5/11 • Number of events 5
|
30.0%
3/10 • Number of events 3
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14 • Number of events 1
|
36.4%
4/11 • Number of events 4
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal Distension
|
28.6%
4/14 • Number of events 4
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Incision Site Pain
|
21.4%
3/14 • Number of events 3
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 2
|
18.2%
2/11 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Wound Infection
|
7.1%
1/14 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Investigations
Potassium Decreased
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/14
|
18.2%
2/11 • Number of events 2
|
0.00%
0/10
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Cardiac disorders
Sinus tachycardia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Cardiac disorders
Supraventricular extrasystoles
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/14
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Cardiac disorders
Ventricular extrasystoles
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Painful defaecation
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Gastrointestinal disorders
Intestinal functional disorder
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Asthenia
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Pain
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
General disorders
Pyrexia
|
0.00%
0/14
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Suprapubic pain
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/14
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/14
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Blood sodium decreased
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Investigations
Haematocrit decreased
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Investigations
Haemoglobin decreased
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Investigations
Lymphocyte count decreased
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Investigations
Neutrophil count increased
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Investigations
Platelet count decreased
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Investigations
Red blood cell count decreased
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Investigations
Weight decreased
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Investigations
Blood phosphorus decreased
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Urine output decreased
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/14
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/14
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Nervous system disorders
Burning sensation
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14
|
18.2%
2/11 • Number of events 2
|
0.00%
0/10
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/14
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Nervous system disorders
Syncope
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/14
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/14
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/14
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Pneumaturia
|
0.00%
0/14
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/14
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/14
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Number of events 1
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/14
|
0.00%
0/11
|
10.0%
1/10 • Number of events 1
|
|
Vascular disorders
Hypotension
|
7.1%
1/14 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
0.00%
0/10
|
Additional Information
Dr. Allen Mangel, Chief Medical Officer
Tioga Pharmaceuticals
Phone: 919-485-5668
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator understands and agrees that the first publication of the results of the Research Study, if any, shall be a multicenter publication of the results from all sites. Institution shall not publish, present, or use any results of the Research Study for any purpose until such Research Study has been completed in its entirety at all sites and until such multi-center study publication has been published or for a period of one year following such completion, whichever occurs first.
- Publication restrictions are in place
Restriction type: OTHER