Nortiptyline for idiopathic gastroparesis: a multicenter, randomized, double-masked, placebo-controlled trial

IRB number: HUM00021678

Enrollment Status: OPEN

The purpose of this study is to find out whether treatment with the medication nortriptyline is better than a placebo in improving the symptoms of patients with gastroparesis &ndash specifically, the type of gastropareisis called "idiopathic", which means "of unknown cause or origin." Nortriptyline is approved by the United States Food and Drug Administration for treatment of depression. It is not currently approved for symptoms of gastroparesis.

Eligibility

Age Range: From 21 to 65 years

Gender: Male & female

Ethnicity: All

Race: All

Smoking: Both smoking and nonsmoking volunteers

Medication: Not taking medication

Study population: patients with symptoms of gastroparesis

Other Eligibility Factors

• Documentation of delayed gastric emptying within 2 years.
• Negative upper endoscopy or upper GI series within 2 years of registration date.
• Symptoms of gastroparesis for at least 6 months (does not have to be contiguous

Prinicipal Investigator:

• William L Hasler, MD

Contact:

• Nara Wootten 734-615-6723 or e-mail: smao@med.umich.edu

This clinical study is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). For more information provided by NIDDK, click on the link to the Nortriptyline for Idiopathic Gastroparesis study at the following web address: http://www.clinicaltrials.gov/ct2/show/NCT00765895?term=gastroparesis&rank=9