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

This study has been completed.
Information provided by:
Tranzyme, Inc. Identifier:
First received: March 14, 2011
Last updated: May 23, 2011
Last verified: May 2011
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.

Diabetes Mellitus Gastroparesis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Protocol for the Patient Understanding (Cognitive Debriefing) of a Modified Gastroparesis Cardinal Symptom Index (GCSI) Daily Diary

Further study details as provided by Tranzyme, Inc.:

Primary Outcome Measures:
  • Qualitative, Content Analysis of Cognitive Debriefing Data [ Time Frame: 90-minute interview ]
    The cognitive debriefing data will be content analyzed for patient understanding of the concepts in the questionnaire and interpretation of the items' content.

Estimated Enrollment: 40
Study Start Date: March 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
No Treatment
Adult subjects with diabetes mellitus and a diagnosis of gastroparesis


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital/Clinic Database

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01316484

United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27517
United States, Pennsylvania
Temple University Health Sciences Center
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905
Sponsors and Collaborators
Tranzyme, Inc.
Principal Investigator: Henry Parkman, MD Temple University Health Sciences Center
Principal Investigator: Tuba Esfandyari, MD University of Kansas Medical Center
Principal Investigator: Irene Sarosiek, MD Texas Tech University Health Sciences Center
Principal Investigator: Kenneth Koch, MD Wake Forest University Health Sciences
  More Information

Responsible Party: Robert P. Venuti, Director, Clinical Development, Tranzyme, Inc Identifier: NCT01316484     History of Changes
Other Study ID Numbers: TZP-QM-001
Study First Received: March 14, 2011
Last Updated: May 23, 2011

Keywords provided by Tranzyme, Inc.:
Cognitive Debriefing

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on September 21, 2017