A Phase II Randomized, Double-Blind, Double-Dummy, Parallel Group, Placebo Controlled Study of Galantamine + Sertraline, Galantamine or Sertraline in Obese Subjects
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10029883Term: ObesityObesity
- Registration Number
- EUCTR2007-000762-20-SE
- Lead Sponsor
- Theracos, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
1. Age = 30 and = 60 years old
2. Body mass index (BMI) is = 30 kg/m2 and = 40 kg/m2
3. Completed at least 80% of the 7-day diet diary
4. Women of childbearing potential with a negative pregnancy test prior to study entry and who agree to use an acceptable method of contraception throughout the study. Criteria for menopause are surgical menopause (hysterectomy, oophorectomy) or age > 45 with absence of menses for at least 12 months. In those subjects = 45 years an elevated serum FSH and the absence of menses for at least 12 months is required.
5. Able to read and give written informed consent and have signed a consent form approved by the Investigator's Institutional Review Board (IRB) or Ethics Committee (EC)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Women who are pregnant or lactating
2. Allergy to galantamine or sertraline or to any of the excipients
3. Have lost more than 3 kg in the 3 months prior to the screening visit
4. Current or previous use (within 3 months of randomization) of medications that influence weight
5. Current or previous use (within 14 days of randomization) with a MAOI (e.g., phenelzine, tranylcypromine), pimozide or cholinesterase inhibitor drugs (e.g., donezepil, rivastigmine, tacrine), or SSRI drugs (e.g., citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline) or SNRI drugs (e.g., duloxetine, venlafaxine, buproprion), or tricyclic antidepressants (e.g., amitriptyline, doxepin, nortriptyline), or ergot drugs (e.g., ergotamine, dihydroergotamine, caffeine/ergotamine combinations, other combination drugs containing ergotamine) or triptans (e.g., sumatriptan, naratriptan, rizatriptan, almotriptan, zolmitriptan, eletriptan, frovatriptan)
6. Current use of cimetidine, ketoconazole, warfarin
7. Current history of atherosclerosis including cardiovascular disease (myorardial infarction, coronary artery bypass grafting, intracoronary stenting, percutaneous transluminal angioplasty or angina pectoris), peripheral vascular disease and cerebrovascular disease (including transient ischemic attack)
8. Current acute or chronic liver disease, including acute hepatitis, chronic hepatitis, or cirrhosis; elevated total bilirubin > 1.5X ULN, elevated transaminases ALT and AST > 2X ULN or elevated GGT, or elevated alkaline phosphatase 2.5 x ULN
9. Known endocrine origin for the subject's obesity, such as hypothyroidism and Cushing's syndrome
10. Current or history of eating disorder such as bulimia, anorexia nervosa, binge eating or laxative abuse
11. Current serious/unstable medical condition including uncontrolled hypertension, active disease of the central nervous system such as seizure disorder, psychiatric illness (including major depression) or uncontrolled infection
12. Current or history of abnormality of cardiac conduction, including first and second degree heart block
13. History of mania/hypomania; history of suicide attempts or suicidal ideation or score indicative of major depression on a depression inventory test
14. Major surgery in last 30 days or planned in next 6 months
15. Current pharmacologically treated diabetes or fasting plasma glucose = 126 mg/dL
16. Current active peptic ulcer disease or urinary outflow obstructive disorder and subjects at risk for urinary outflow obstruction such as those with clinecally significant benign prostatic hypertrophy or atonic bladder
17. Current asthma or chronic obstructive pulmonary disease
18. Current or history of renal disease or serum creatinine = 1.5 mg/dl
19. Current or history (within the past year) of alcohol, drug or other substance abuse
20. Participation in another experimental drug or device treatment protocol within the 30 days prior to screening or are scheduled to receive such a drug during the study period
21. Subjects who are not willing or able to fully comply with the protocol
22. Subjects whom the investigator believes to be medically unfit to receive the study treatment, or unsuitable for any other reason
23. Subjects who have previously entered this study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method