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NCT01316484 Clinical Trial

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

Diabetes Mellitus Clinical Trial

Official title:
Protocol for the Patient Understanding (Cognitive Debriefing) of a Modified Gastroparesis Cardinal Symptom Index (GCSI) Daily Diary

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01316484
Other study ID # TZP-QM-001
Secondary ID
Status Completed
Phase N/A
First received March 14, 2011
Last updated May 23, 2011
Start date March 2011
Est. completion date April 2011

Study information
Verified date May 2011
Source Tranzyme, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States Texas Tech University Health Sciences Center El Paso Texas
United States University of Kansas Medical Center Kansas City Kansas
United States Temple University Health Sciences Center Philadelphia Pennsylvania
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Tranzyme, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Qualitative, Content Analysis of Cognitive Debriefing Data The cognitive debriefing data will be content analyzed for patient understanding of the concepts in the questionnaire and interpretation of the items' content. 90-minute interview No
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