Trial Outcomes & Findings for A Randomized, Double-blind Study of the Effects of Fenretinide Administered in Subjects With Obesity (NCT NCT00546455)

NCT ID: NCT00546455

Last Updated: 2021-02-10

Results Overview

This study was terminated due to expired drug with possibility of re-starting in the future. For this reason the randomization code has not been broken and the data has not been analyzed and there is no way to report the outcome measures.

Recruitment status

SUSPENDED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

30 days

Results posted on

2021-02-10

Participant Flow

This study was terminated due to expired drug with possibility of re-starting in the future. For this reason the randomization code has not been broken and the data has not been analyzed and there is no way to report the participant flow.

Participant milestones

Participant milestones
Measure
A- Fenretinide
Subjects in this cohort will be given Fenretinide Fenretinide: 200 mg/day
B-Placebo
Subjects in this cohort will be given placebo. Placebo: 2 capsules/day
Overall Study
STARTED
0
0
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized, Double-blind Study of the Effects of Fenretinide Administered in Subjects With Obesity

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 30 days

Population: This study was terminated due to expired drug with possibility of re-starting in the future. For this reason the randomization code has not been broken and the data has not been analyzed and there is no way to report the outcome measures.

This study was terminated due to expired drug with possibility of re-starting in the future. For this reason the randomization code has not been broken and the data has not been analyzed and there is no way to report the outcome measures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Population: This study was terminated due to expired drug with possibility of re-starting in the future. For this reason the randomization code has not been broken and the data has not been analyzed and there is no way to report the outcome measures.

This study was terminated due to expired drug with possibility of re-starting in the future. For this reason the randomization code has not been broken and the data has not been analyzed and there is no way to report the outcome measures.

Outcome measures

Outcome data not reported

Adverse Events

A- Fenretinide

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

B-Placebo

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

MARIO CHOJKIER

UCSD

Phone: 858-552-8585

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place