Trial Outcomes & Findings for A Study of the Efficacy of Subcutaneous Phosphatidylcholine and Deoxycholate Injections for Localized Fat Removal (NCT NCT00851747)

Results Overview

The primary objective of this study is to determine the efficacy of phosphatidylcholine and deoxycholate subcutaneous injections for localized fat removal. Subcutaneous injections of the study drug will be efficacious in decreasing localized fat deposits

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

1 year

Results posted on

2018-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	A Saline Group A will serve as a control and will receive only injections of saline as a placebo.	B PhosphatidylcholineDeoxycholate/Saliine Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side	C Phosphatidylcholine Deoxycholate Phosphatidylcholine Deoxycholate Injections Group C will receive only study drug injections
Overall Study STARTED	6	6	6
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	6	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	A Saline Group A will serve as a control and will receive only injections of saline as a placebo.	B PhosphatidylcholineDeoxycholate/Saliine Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side	C Phosphatidylcholine Deoxycholate Phosphatidylcholine Deoxycholate Injections Group C will receive only study drug injections
Overall Study Physician Decision	6	6	6

Baseline Characteristics

PI left institution no data available.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	C Phosphatidylcholine Deoxycholate n=6 Participants Phosphatidylcholine Deoxycholate Injections	A Saline n=6 Participants Group A will serve as a control and will receive only injections of saline as a placebo.	B PhosphatidylcholineDeoxycholate/Saline n=6 Participants Group B will receive saline injections on one side of the body and receive PhosphatidylcholineDeoxycholate injections on the contralateral side.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	—	—	—	0 Participants PI left institution no data available.
Age, Categorical Between 18 and 65 years	—	—	—	0 Participants PI left institution no data available.
Age, Categorical >=65 years	—	—	—	0 Participants PI left institution no data available.
Sex: Female, Male Female	0 Participants No analysis completed. PI left the Institution	0 Participants No analysis completed. PI left the Institution	0 Participants No analysis completed. PI left the Institution	0 Participants No analysis completed. PI left the Institution
Sex: Female, Male Male	0 Participants No analysis completed. PI left the Institution	0 Participants No analysis completed. PI left the Institution	0 Participants No analysis completed. PI left the Institution	0 Participants No analysis completed. PI left the Institution

PRIMARY outcome

Timeframe: 1 year

Population: PI left institution and no data is available.

The primary objective of this study is to determine the efficacy of phosphatidylcholine and deoxycholate subcutaneous injections for localized fat removal. Subcutaneous injections of the study drug will be efficacious in decreasing localized fat deposits

Outcome measures

Outcome data not reported

Adverse Events

C Phosphatidylcholine Deoxycholate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

A Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B PhosphatidylcholineDeoxycholate/Saline

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

Rebecca Tung, MD

Loyola Medical Center

Phone: (708) 216-4962

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place