NCT01035333

Brief Summary

The primary goal of the study is to determine if orlistat 60mg (Alli) is effective in helping patients achieve a required 10% weight loss goal prior to bariatric surgery. The medication will be added to the usual standard of care which includes education regarding diet and exercise and monthly meetings with a registered dietician.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4 obesity

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 15, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
3 years until next milestone

Results Posted

Study results publicly available

April 4, 2014

Completed
Last Updated

April 4, 2014

Status Verified

February 1, 2014

Enrollment Period

1.4 years

First QC Date

December 15, 2009

Results QC Date

January 8, 2014

Last Update Submit

February 25, 2014

Conditions

Obesity

Keywords

gastric bypass surgery

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

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

    6 months

Secondary Outcomes (1)

  • Patient Satisfaction

    6 months

Study Arms (1)

orlistat 60mg

EXPERIMENTAL

Patients assigned to treatment group for up to 6 months of therapy.

Drug: Orlistat

Interventions

OrlistatDRUG

60mg capsule three times a day for up to 6 months

Also known as: Alli
orlistat 60mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients preparing for gastric bypass surgery

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albany College of Pharmacy and Health Sciences

Albany, New York, 12208, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Orlistat

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic Chemicals

Limitations and Caveats

High drop out rate. Patients did not return to clinic and were lost to follow up.

Results Point of Contact

Title
Dr Margaret Malone
Organization
Albany College of Pharmacy and Health Sciences
margaret.malone@acphs.edu
518 694 7275

Study Officials

  • Margaret Malone, PhD

    Albany College of Pharmacy and Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 15, 2009

First Posted

December 18, 2009

Study Start

November 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

April 4, 2014

Results First Posted

April 4, 2014

Record last verified: 2014-02

Locations

US(1)