Trial Outcomes & Findings for A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery. (NCT NCT01035333)

Results Overview

Weight loss acheived during time on study up to 6 months.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

6 months

Results posted on

2014-04-04

Participant Flow

Dates of recruitment 10.14.09 to 12.15.10 Outpatient clinic, Bariatric treatment Center

Participant milestones

Participant milestones
Measure	Orlistat 60mg Patients assigned to treatment group for up to 6 months of therapy.
Overall Study STARTED	19
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of the Efficacy of Alli in the Management of Pre-operative Weight Loss Required for Bariatric Surgery.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Orlistat 60mg n=19 Participants Patients assigned to treatment group for up to 6 months of therapy.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	40.9 years STANDARD_DEVIATION 11.4 • n=99 Participants
Sex: Female, Male Female	14 Participants n=99 Participants
Sex: Female, Male Male	5 Participants n=99 Participants
Region of Enrollment United States	19 participants n=99 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All patients data who were entered were analyzed, 19 recruited, 15 at 3 months, 9 at 6 months.

Weight loss acheived during time on study up to 6 months.

Outcome measures

Outcome measures
Measure	Orlistat 60mg n=9 Participants Patients assigned to treatment group for up to 6 months of therapy.
Weight Loss	2.0 percentage of weight Standard Deviation 3.4

SECONDARY outcome

Timeframe: 6 months

Population: Patients who completed 6 months of the study.

Outcome measures

Outcome measures
Measure	Orlistat 60mg n=9 Participants Patients assigned to treatment group for up to 6 months of therapy.
Patient Satisfaction	9 participants

Adverse Events

Orlistat 60mg

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

Dr Margaret Malone

Albany College of Pharmacy and Health Sciences

Phone: 518 694 7275

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place