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

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ClinicalTrials.gov Identifier: NCT01316484
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : May 24, 2011
Sponsor:
Information provided by:
Tranzyme, Inc.

Brief 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.

Condition or disease
Diabetes Mellitus Gastroparesis

Study Type : Observational
Estimated Enrollment : 40 participants
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
Study Start Date : March 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
No Treatment
Adult subjects with diabetes mellitus and a diagnosis of gastroparesis



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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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
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Medical Center
Principal Investigator: Irene Sarosiek, MD Texas Tech University Health Sciences Center
Principal Investigator: Kenneth Koch, MD Wake Forest University Health Sciences

Responsible Party: Robert P. Venuti, Director, Clinical Development, Tranzyme, Inc
ClinicalTrials.gov Identifier: NCT01316484     History of Changes
Other Study ID Numbers: TZP-QM-001
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: May 24, 2011
Last Verified: May 2011

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