Trial Outcomes & Findings for Analysis of Lipid Biomarkers of Exposure and Host Response (NCT NCT00493831)
NCT ID: NCT00493831
Last Updated: 2023-09-07
Results Overview
No data were collected
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-09-07
Participant Flow
24 subjects were recruited, but only 20 proceeded to the intervention. Some information was collected from all 20, although outcomes were not measurable in any.
Participant milestones
| Measure |
Nicotine Replacement Therapy
open label self comparison study design
nicotine polacrilex, transdermal system or inhaler
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Analysis of Lipid Biomarkers of Exposure and Host Response
Baseline characteristics by cohort
| Measure |
Nicotine Replacement Therapy
n=20 number
any form of nicotine replacement would be allowed at subject discretion
nicotine polacrilex, transdermal system or inhaler: on label use of NRT
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Study withdrawn so no data available for analysis. No data collected.
No data were collected
Outcome measures
Outcome data not reported
Adverse Events
Nicotine Replacement Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place