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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

March 14, 2011
May 23, 2011
March 2011
April 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01316484 on ClinicalTrials.gov Archive Site
Not Provided
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Patient Understanding (Cognitive Debriefing) of a Daily Diary of Gastroparesis Symptoms
Protocol for the Patient Understanding (Cognitive Debriefing) of a Modified Gastroparesis Cardinal Symptom Index (GCSI) Daily Diary

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

Hospital/Clinic Database

  • Diabetes Mellitus
  • Gastroparesis
Not Provided
No Treatment
Adult subjects with diabetes mellitus and a diagnosis of gastroparesis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2011
April 2011   (final data collection date for primary outcome measure)

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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Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01316484
TZP-QM-001
No
Robert P. Venuti, Director, Clinical Development, Tranzyme, Inc
Tranzyme, Inc.
Not Provided
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 School of Medicine
Tranzyme, Inc.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP