Effects of baclofen on body weight in obese patients

UMIN ID: UMIN000001573

Registered date:15/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: obesity
• Date of first enrollment: 2008/11/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): All patients will be administered baclofen (three times a day) for 12 weeks. The amount of baclofen is 15 mg/day for day1-3, 20 mg/day for day 4-6, 25 mg/day for day 7-9, and 30 mg/day for day 10-84, unless there are side effects such as sleepness, muscular weakness, nausea and anorexia.

Outcome(s)

• Primary Outcome: body weight, waist size
• Secondary Outcome: parameters related to glucose and lipid metabolism, blood pressure, appetite

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: patients with renal failure (Cr 1.5 mg/dl or more), insulin therapy, pregnancy or possible pregnancy, epilepsy (including its past history), mental diseases, ulcer or respiratoy failure patients who have been taking sleeping pills patients who the doctor judges should not be involved in the study

Related Information

• Primary Sponsor: Department of Endocrinology and Diabetes, Nagoya University Graduate School of Medicine
• Secondary Sponsor: None
• Source(s) of Monetary Support: None,None