Patient Understanding (Cognitive Debriefing) of a Daily Diary of Gastroparesis Symptoms

Completed

Conditions studied: Diabetes Mellitus, Gastroparesis

In brief

The primary objective of the study is to evaluate how patients with gastroparesis interpret the instructions, item content, and response options of a daily diary questionnaire designed to assess the key symptoms of gastroparesis.

Key facts

Study ID

NCT01316484

Run by

Tranzyme, Inc.

People needed

40

Starts

2011-03-01

Expected to finish

2011-04-01

Last updated by the study team

2011-05-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has Type 1 or Type 2 diabetes mellitus
• Subject is 18 to 70 years old
• Subject has chronic, active symptoms of gastroparesis for at least the past three months
• Subject has confirmed delayed gastric emptying by scintigraphy, a breath test, or the SmartPill® wireless motility capsule
• Subject can speak and read English
• Subject is able to give his/her informed consent

You may not qualify if…

• Subject has a cognitive, psychological or other (e.g., visual) impairment that would interfere with completing the study visit

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Temple University Health Sciences Center — Philadelphia, Pennsylvania, United States
• Texas Tech University Health Sciences Center — El Paso, Texas, United States

Full record on ClinicalTrials.gov

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