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Trial record 23 of 69 for:    ORLISTAT

Safety and Efficacy of Xenical in Children and Adolescents With Obesity-Related Diseases

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: NCT00001723
Recruitment Status : Completed
First Posted : November 4, 1999
Results First Posted : December 18, 2012
Last Update Posted : December 18, 2012
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Roche Pharma AG
Information provided by (Responsible Party):
Jack Yanovski, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Diabetes Mellitus
Hypertension
Metabolic Disease
Obesity
Sleep Apnea Syndrome
Interventions Drug: Orlistat
Drug: Placebo
Enrollment 200
Recruitment Details Accrual for RCT began in 1999 and ended in 2008. All subjects were screened at the NIH Clinical Center.
Pre-assignment Details Most subjects screened but not enrolled (101) did not have an obesity-related comorbid condition (i.e., hypertension or dyslipidemia). 16 met a medical exclusion, and 13 declined participation after undergoing initial evaluation.
Arm/Group Title Orlistat Placebo
Hide Arm/Group Description

Orlistat 120 mg TID for 6 months plus a behavioral weight loss program

Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.

Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program

Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.

Period Title: Overall Study
Started 100 100
Completed 87 84
Not Completed 13 16
Reason Not Completed
Lack of Efficacy             6             7
Lack of family interest             4             5
Lost to Follow-up             2             2
medication intolerance             1             2
Arm/Group Title Orlistat Placebo Total
Hide Arm/Group Description

Orlistat 120 mg TID for 6 months plus a behavioral weight loss program

Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.

Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program

Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.

Total of all reporting groups
Overall Number of Baseline Participants 100 100 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
<=18 years
100
 100.0%
100
 100.0%
200
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 100 participants 200 participants
14.65  (1.38) 14.52  (1.46) 14.59  (1.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Female
65
  65.0%
66
  66.0%
131
  65.5%
Male
35
  35.0%
34
  34.0%
69
  34.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 100 participants 100 participants 200 participants
100 100 200
1.Primary Outcome
Title Change in BMI Standard Deviation Score
Hide Description Body Mass index standard deviation score calculated for age and sex according to Centers for Disease Control standards. See: Kuczmarski RJ, Ogden CL, Guo SS, Grummer-Strawn LM, Flegal KM, Mei Z et al. 2000 CDC Growth Charts for the United States: methods and development. Vital Health Stat 11 2002; (246): 1-190.
Time Frame baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Multiple imputation analysis
Arm/Group Title Orlistat Placebo
Hide Arm/Group Description:

Orlistat 120 mg TID for 6 months plus a behavioral weight loss program

Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.

Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program

Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.

Overall Number of Participants Analyzed 100 100
Mean (Standard Error)
Unit of Measure: Standard Deviation Score
-0.12  (0.02) -0.06  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Orlistat, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change in Body Weight
Hide Description Weight in kg
Time Frame baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Multiple imputation analysis
Arm/Group Title Orlistat Placebo
Hide Arm/Group Description:

Orlistat 120 mg TID for 6 months plus a behavioral weight loss program

Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.

Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program

Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.

Overall Number of Participants Analyzed 100 100
Mean (Standard Error)
Unit of Measure: kg
-2.9  (0.7) -0.6  (0.7)
3.Secondary Outcome
Title Change in Body Mass Index
Hide Description BMI is calculated in kg/m2. Change from baseline to 6 months of treatment
Time Frame baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Muliple imputation analysis
Arm/Group Title Orlistat Placebo
Hide Arm/Group Description:

Orlistat 120 mg TID for 6 months plus a behavioral weight loss program

Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.

Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program

Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.

Overall Number of Participants Analyzed 100 100
Mean (Standard Error)
Unit of Measure: kg per square meter
-1.44  (0.26) -0.50  (0.20)
4.Secondary Outcome
Title Change in Body Fat (kg)
Hide Description body fat distribution measures obtained from Dual-energy X-ray Absorptiometry (DEXA)
Time Frame baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Multiple Imputation analysis
Arm/Group Title Orlistat Placebo
Hide Arm/Group Description:

Orlistat 120 mg TID for 6 months plus a behavioral weight loss program

Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.

Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program

Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.

Overall Number of Participants Analyzed 100 100
Mean (Standard Error)
Unit of Measure: kg
-3.2  (0.55) -1.7  (0.53)
5.Secondary Outcome
Title Effect of Race on Change in Weight (kg)
Hide Description Difference in change of weight in kg according to race (Non-Hispanic White versus Non-Hispanic Black)
Time Frame baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Multiple imputation analysis
Arm/Group Title Orlistat - Non-Hispanic Blacks Orlistat - Non- Hispanic Whites Placebo - Non-Hispanic Blacks Placebo - Non-Hispanic Whites
Hide Arm/Group Description:
Change in weight for Non-Hispanic Black participants treated with orlistat
Change in weight for Non-Hispanic White participants treated with orlistat
Change in weight for Non-Hispanic Black participants treated with placebo
Change in weight for Non-Hispanic White participants treated with placebo
Overall Number of Participants Analyzed 63 37 60 40
Mean (Standard Error)
Unit of Measure: kg
-2.126  (0.812) -3.742  (1.046) 0.415  (0.835) -1.580  (1.013)
Time Frame 6 months of randomized treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Orlistat Placebo
Hide Arm/Group Description Orlistat 120 mg TID for 6 months plus a behavioral weight loss program Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months. Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
All-Cause Mortality
Orlistat Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Orlistat Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   2/100 (2.00%) 
Endocrine disorders     
Hypoglycemia - pharmacy error in preparing insulin  1  0/100 (0.00%)  1/100 (1.00%) 
Gastrointestinal disorders     
Left lower quadrant pain and vomiting - admitted overnight  1  0/100 (0.00%)  1/100 (1.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE_4.03
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Orlistat Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   95/100 (95.00%)   94/100 (94.00%) 
Ear and labyrinth disorders     
ear disorders (otitis, earache, ear pain)  1  7/100 (7.00%)  7/100 (7.00%) 
Eye disorders     
eye disorders (change in vision, conjunctivitis, styes)  1  8/100 (8.00%)  9/100 (9.00%) 
Gastrointestinal disorders     
abdominal pain or cramping  1  16/100 (16.00%)  21/100 (21.00%) 
bloating or gas  1  18/100 (18.00%)  5/100 (5.00%) 
BORBORYGMI  1  6/100 (6.00%)  2/100 (2.00%) 
constipation  1  1/100 (1.00%)  7/100 (7.00%) 
Controlled discharge of oil without stool  1  56/100 (56.00%)  11/100 (11.00%) 
Decreased frequency of bowel movements  1  25/100 (25.00%)  22/100 (22.00%) 
diarrhea  1  21/100 (21.00%)  8/100 (8.00%) 
fatty-appearing stools  1  61/100 (61.00%)  6/100 (6.00%) 
flatulence (passage of gas)  1  60/100 (60.00%)  47/100 (47.00%) 
flatus with discharge  1  43/100 (43.00%)  11/100 (11.00%) 
frequent urge for bowel movement  1  19/100 (19.00%)  3/100 (3.00%) 
hiccups  1  1/100 (1.00%)  3/100 (3.00%) 
Increased frequency of bowel movements  1  68/100 (68.00%)  45/100 (45.00%) 
NAUSEA  1  10/100 (10.00%)  9/100 (9.00%) 
oily spotting  1  6/100 (6.00%)  0/100 (0.00%) 
rectal bleeding - hemorrhoids  1  4/100 (4.00%)  2/100 (2.00%) 
soft or deliquescent stools  1  68/100 (68.00%)  42/100 (42.00%) 
stomach pain or cramps  1  8/100 (8.00%)  9/100 (9.00%) 
Stools almost all liquid with very few solid parts  1  64/100 (64.00%)  34/100 (34.00%) 
Stools hard and in the shape of small pellets  1  11/100 (11.00%)  10/100 (10.00%) 
Stools mixed with fat or with a separate oily layer  1  83/100 (83.00%)  18/100 (18.00%) 
uncontrolled passage of stool or oil  1  60/100 (60.00%)  11/100 (11.00%) 
Urgent, but controlled, need to produce stools  1  44/100 (44.00%)  18/100 (18.00%) 
Vomiting  1  7/100 (7.00%)  7/100 (7.00%) 
General disorders     
dizziness  1  4/100 (4.00%)  4/100 (4.00%) 
epistaxis  1  5/100 (5.00%)  2/100 (2.00%) 
feeling cold  1  5/100 (5.00%)  2/100 (2.00%) 
headache  1  14/100 (14.00%)  17/100 (17.00%) 
increased sweating  1  3/100 (3.00%)  4/100 (4.00%) 
increased thirst  1  5/100 (5.00%)  4/100 (4.00%) 
sinusitis, post-nasal drip or nasal stuffiness  1  2/100 (2.00%)  5/100 (5.00%) 
unusual tiredness or weakness (fatigue)  1  1/100 (1.00%)  5/100 (5.00%) 
Infections and infestations     
Pharyngitis  1  6/100 (6.00%)  12/100 (12.00%) 
sinusitis, post-nasal drip or nasal stuffiness  1  1/100 (1.00%)  3/100 (3.00%) 
Metabolism and nutrition disorders     
decrease in appetite  1  11/100 (11.00%)  9/100 (9.00%) 
Musculoskeletal and connective tissue disorders     
muscle pain, stiffness, cramps, or ache  1  16/100 (16.00%)  12/100 (12.00%) 
Nervous system disorders     
migraine headaches  1  3/100 (3.00%)  0/100 (0.00%) 
Psychiatric disorders     
mental depression  1  1/100 (1.00%)  3/100 (3.00%) 
Renal and urinary disorders     
dysuria or UTI  1  1/100 (1.00%)  5/100 (5.00%) 
nocturia  1  0/100 (0.00%)  3/100 (3.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma symptoms  1  5/100 (5.00%)  3/100 (3.00%) 
cough  1  0/100 (0.00%)  7/100 (7.00%) 
Upper Respiratory Infection  1  14/100 (14.00%)  17/100 (17.00%) 
Skin and subcutaneous tissue disorders     
skin rash  1  5/100 (5.00%)  2/100 (2.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE_4.03
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jack A. Yanovski, MD, PhD, Chief SGO, PDEGEN
Organization: National Institute of Child Health and Human Development, NIH
Phone: 301-496-4686
EMail: yanovskj@mail.nih.gov
Layout table for additonal information
Responsible Party: Jack Yanovski, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00001723     History of Changes
Other Study ID Numbers: 980111
98-CH-0111 ( Other Identifier: NICHD IRB )
First Submitted: November 3, 1999
First Posted: November 4, 1999
Results First Submitted: October 11, 2012
Results First Posted: December 18, 2012
Last Update Posted: December 18, 2012