Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 21 of 69 for:    ORLISTAT

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01035333
Recruitment Status : Completed
First Posted : December 18, 2009
Results First Posted : April 4, 2014
Last Update Posted : April 4, 2014
Sponsor:
Collaborator:
Albany Medical College
Information provided by (Responsible Party):
Margaret Malone, Albany College of Pharmacy and Health Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obesity
Intervention Drug: Orlistat
Enrollment 19
Recruitment Details Dates of recruitment 10.14.09 to 12.15.10 Outpatient clinic, Bariatric treatment Center
Pre-assignment Details  
Arm/Group Title Orlistat 60mg
Hide Arm/Group Description Patients assigned to treatment group for up to 6 months of therapy.
Period Title: Overall Study
Started 19
Completed 9
Not Completed 10
Arm/Group Title Orlistat 60mg
Hide Arm/Group Description Patients assigned to treatment group for up to 6 months of therapy.
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
19
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
40.9  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
14
  73.7%
Male
5
  26.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants
19
1.Primary Outcome
Title Weight Loss
Hide Description Weight loss acheived during time on study up to 6 months.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients data who were entered were analyzed, 19 recruited, 15 at 3 months, 9 at 6 months.
Arm/Group Title Orlistat 60mg
Hide Arm/Group Description:
Patients assigned to treatment group for up to 6 months of therapy.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: percentage of weight
2.0  (3.4)
2.Secondary Outcome
Title Patient Satisfaction
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed 6 months of the study.
Arm/Group Title Orlistat 60mg
Hide Arm/Group Description:
Patients assigned to treatment group for up to 6 months of therapy.
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
9
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Orlistat 60mg
Hide Arm/Group Description Patients assigned to treatment group for up to 6 months of therapy.
All-Cause Mortality
Orlistat 60mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Orlistat 60mg
Affected / at Risk (%)
Total   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Orlistat 60mg
Affected / at Risk (%)
Total   0/19 (0.00%) 
High drop out rate. Patients did not return to clinic and were lost to follow up.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Margaret Malone
Organization: Albany College of Pharmacy and Health Sciences
Phone: 518 694 7275
EMail: margaret.malone@acphs.edu
Layout table for additonal information
Responsible Party: Margaret Malone, Albany College of Pharmacy and Health Sciences
ClinicalTrials.gov Identifier: NCT01035333     History of Changes
Other Study ID Numbers: 09-016
First Submitted: December 15, 2009
First Posted: December 18, 2009
Results First Submitted: January 8, 2014
Results First Posted: April 4, 2014
Last Update Posted: April 4, 2014