Trial Outcomes & Findings for Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection (NCT NCT01118663)
NCT ID: NCT01118663
Last Updated: 2014-08-04
Results Overview
Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
17 participants
Primary outcome timeframe
21 hours
Results posted on
2014-08-04
Participant Flow
Participant milestones
| Measure |
Acetadote Without EDTA
Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]
Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]: Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours
|
Acetadote
Acetadote \[Old formulation containing EDTA\]
Acetadote: Acetadote \[old formulation\] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
10
|
|
Overall Study
COMPLETED
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Acetadote Without EDTA
Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]
Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]: Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours
|
Acetadote
Acetadote \[Old formulation containing EDTA\]
Acetadote: Acetadote \[old formulation\] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection
Baseline characteristics by cohort
| Measure |
Acetadote Without EDTA
n=7 Participants
Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]
Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]: Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours
|
Acetadote
n=10 Participants
Acetadote \[Old formulation containing EDTA\]
Acetadote: Acetadote \[old formulation\] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
≤ 18 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Age, Customized
19-59 years
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Age, Customized
≥ 60 years
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
10 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 hoursPopulation: Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.
Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 21 hoursPopulation: Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.
Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 42 hoursPopulation: Because the study was terminated prematurely due to lack of enrollment, there was insufficient sample size to conduct efficacy analysis.
Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 21-42 hoursOutcome measures
| Measure |
Acetadote Without EDTA
n=7 Participants
Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]
Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]: Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours
|
Acetadote
n=10 Participants
Acetadote \[Old formulation containing EDTA\]
Acetadote: Acetadote \[old formulation\] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours.
|
|---|---|---|
|
To Evaluate the Incidence of Treatment Emergent Adverse Events
|
13 Number of Events
|
14 Number of Events
|
SECONDARY outcome
Timeframe: 1 hourData analysis was conducted on the subjects enrolled in the study prior to study termination. Because the study was terminated prematurely due to lack of enrollment, there was an insufficient sample size to conduct an efficacy analysis.
Outcome measures
| Measure |
Acetadote Without EDTA
n=7 Participants
Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]
Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]: Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours
|
Acetadote
n=10 Participants
Acetadote \[Old formulation containing EDTA\]
Acetadote: Acetadote \[old formulation\] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours.
|
|---|---|---|
|
To Evaluate the Incidence of Anaphylactoid Reaction.
|
0 participants
|
1 participants
|
Adverse Events
Acetadote Without EDTA
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Acetadote
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Acetadote Without EDTA
n=7 participants at risk
Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]
Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\]: Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours
|
Acetadote
n=10 participants at risk
Acetadote \[Old formulation containing EDTA\]
Acetadote: Acetadote \[old formulation\] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Flushing
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Investigations
Blood Potassium Decreased
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Livedo Reticularis
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Number of events 1
|
10.0%
1/10 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
3/7 • Number of events 3
|
30.0%
3/10 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Chest Discomfort
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
Immune system disorders
Anaphylactoid Reaction
|
0.00%
0/7
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Chest Pain
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.6%
2/7 • Number of events 2
|
0.00%
0/10
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Investigations
Blood Magnesium Decreased
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
|
Psychiatric disorders
Agitation
|
14.3%
1/7 • Number of events 1
|
0.00%
0/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place