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

Tranzyme

Status: Completed

Conditions: Gastroparesis; Diabetes Mellitus

Study type: Observational

Funder types: Industry

Identifiers

NCT01316484

TZP-QM-001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

40 participants in 1 patient group

No Treatment

Description:

Adult subjects with diabetes mellitus and a diagnosis of gastroparesis