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

This study has been completed.
Sponsor:
Information provided by:
Tranzyme, Inc.
ClinicalTrials.gov Identifier:
NCT01316484
First received: March 14, 2011
Last updated: May 23, 2011
Last verified: May 2011
History of Changes
  Purpose

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.


Condition
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Tranzyme, Inc.:

Primary Outcome Measures:
  • Qualitative, Content Analysis of Cognitive Debriefing Data [ Time Frame: 90-minute interview ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts
No Treatment
Adult subjects with diabetes mellitus and a diagnosis of gastroparesis

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospital/Clinic Database

Criteria

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

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

Locations
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.
Investigators
Principal Investigator: Henry Parkman, MD Temple University Health Sciences Center
Principal Investigator: Tuba Esfandyari, MD University of Kansas
Principal Investigator: Irene Sarosiek, MD Texas Tech University Health Sciences Center
Principal Investigator: Kenneth Koch, MD Wake Forest University
  More Information

No publications provided

Responsible Party: Robert P. Venuti, Director, Clinical Development, Tranzyme, Inc
ClinicalTrials.gov Identifier: NCT01316484     History of Changes
Other Study ID Numbers: TZP-QM-001
Study First Received: March 14, 2011
Last Updated: May 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Tranzyme, Inc.:
Cognitive Debriefing

Additional relevant MeSH terms:
Diabetes Mellitus
Gastroparesis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Stomach Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013