Comparing the Effect of Under the Tongue Olanzapine Versus Swallowed Olanzapine on Body Mass Index (A Ratio of Weight to Height)
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00303602
First received: March 15, 2006
Last updated: June 5, 2009
Last verified: June 2009
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Purpose
This study is testing if under the tongue olanzapine for schizophrenia, related psychosis, schizoaffective disorder or bipolar disorder will have less weight gain than olanzapine that is swallowed, in patients who are already gaining weight on olanzapine.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder Bipolar Disorder |
Drug: Sublingual orally disintegrating olanzapine (SODO) Drug: Oral olanzapine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | BMI Evaluation: Placebo and Active Comparator Trial of Olanzapine Zydis Pills Used Sublingually (PLATYPUS) |
Resource links provided by NLM:
MedlinePlus related topics:
Bipolar Disorder
Diabetes Medicines
Mental Disorders
Psychotic Disorders
Schizophrenia
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Time Course of Change From Baseline in Body Mass Index (BMI) [ Time Frame: Visit 2 (Baseline) to Visit 7 (16 Weeks) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
- Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers [ Time Frame: Visit 2 (Baseline) and Visit 7 (16 Weeks) ] [ Designated as safety issue: Yes ]
- Mean Change From Baseline to 16 Week Endpoint in Weight [ Time Frame: Visit 2 (Baseline) and Visit 7 (16 Weeks) ] [ Designated as safety issue: Yes ]
- Mean Change From Baseline to 16 Week Endpoint in Waist Circumference [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
- Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period [ Time Frame: Visit 2 (Baseline) to Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
- Number of Participants Discontinuing the Trial by Visit (Week) [ Time Frame: Visit 2 (Baseline) to Visit 7 (Week 16) ] [ Designated as safety issue: No ]
- Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: No ]
- Mean Change From Baseline to 16 Week Endpoint in Blood Pressure [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
- Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides) [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
- Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
- Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
- Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
- Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated) [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
- Number of Participants Meeting a Definition for the Presence of Metabolic Syndrome as Defined by Adult Treatment Panel III (ATP III) Criteria at Baseline and 16 Week Endpoint [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: Yes ]
- Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: No ]
- Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: No ]
- Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale [ Time Frame: Visit 2 (Baseline) and Visit 7 (Week 16) ] [ Designated as safety issue: No ]
| Enrollment: | 149 |
| Study Start Date: | March 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Sublingual orally disintegrating olanzapine (SODO)
|
Drug: Sublingual orally disintegrating olanzapine (SODO)
5 to 20mg dose, supplied in 5mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks.
Other Names:
|
|
Active Comparator: B
Oral olanzapine
|
Drug: Oral olanzapine
5 to 20mg dose, supplied in 5mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks.
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria (Patients must):
- Be at least 18 years old
- Have gained weight while taking olanzapine
- Be able to visit the doctor's office seven times over 4 months (17 weeks)
Exclusion Criteria (Patients must NOT):
- Have started a weight loss program within the last 8 weeks
- Have an illness that might affect patient's weight during the study
- Have an allergy to phenylalanine, mannitol or saccharine
- Be taking any medication (except for olanzapine) that might affect patient's weight
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00303602
Locations
| United States, California | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Escondido, California, United States, 92025 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Garden Grove, California, United States, 92845 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| National City, California, United States, 91950 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Orange, California, United States, 92868 | |
| United States, Georgia | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Nevada | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Las Vegas, Nevada, United States, 89102 | |
| United States, New York | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Staten Island, New York, United States, 10312 | |
| Canada, British Columbia | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Penticton, British Columbia, Canada, V2A 4M4 | |
| Canada, Manitoba | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Winnipeg, Manitoba, Canada, R3E 3N4 | |
| Canada, Nova Scotia | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Dartmouth, Nova Scotia, Canada, B2Y 3Z9 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Halifax, Nova Scotia, Canada, B3H 2E2 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Sydney, Nova Scotia, Canada, B1S 2E8 | |
| Canada, Ontario | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Chatham, Ontario, Canada, N7L 1B7 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Kingston, Ontario, Canada, K7L 4X3 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Sudbury, Ontario, Canada, P3C 1T4 | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Windsor, Ontario, Canada, N9C 3Z4 | |
| Canada, Quebec | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Sherbrooke, Quebec, Canada, J1G 1W4 | |
| Mexico | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Mexico City, Mexico, 01030 | |
| Netherlands | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Amersfoort, Netherlands, 3816 CP | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| Rotterdam, Netherlands, 3015 GD | |
| Puerto Rico | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | |
| San Juan, Puerto Rico, 00918 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
More Information
Additional Information:
No publications provided by Eli Lilly and Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00303602 History of Changes |
| Other Study ID Numbers: | 10268, F1D-CA-S063 |
| Study First Received: | March 15, 2006 |
| Results First Received: | December 19, 2008 |
| Last Updated: | June 5, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Bipolar Disorder Psychotic Disorders Schizophrenia Affective Disorders, Psychotic Mood Disorders Mental Disorders Schizophrenia and Disorders with Psychotic Features Olanzapine Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 16, 2013