Multicenter Study of Patient-reported Gastrointestinal Symptoms in People With Cystic Fibrosis (GALAXY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03801993|
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : October 2, 2019
|Condition or disease|
There are currently no large, multicenter prospective clinical trials examining management of constipation or other gastrointestinal (GI) symptoms in people with cystic fibrosis (CF). Current recommendations in the CF literature are largely based on expert consensus and opinions. Yet, constipation and other GI symptoms are crucial factors in quality of life (QOL) and maintenance of optimal nutritional state in people with CF. This study will use GI-symptomatology questionnaires to understand the multiple overlapping GI symptoms in people with CF.
Eligible subjects will be consented and enrolled in the study at the Enrollment Visit. At the visit, the subject or parent/guardian will complete the patient reported outcome surveys (PROs) using a mobile device (e.g., smartphone or tablet). The same questionnaires will be completed on a mobile device outside the clinic three additional times. The PROs will consist of four questionnaires: Patient Assessment of Constipation Symptoms (PAC-SYM), Patient Assessment of Gastrointestinal Symptoms (PAGI-SYM), Patient Assessment of Constipation Quality of Life (PAC-QOL) and a disease-specific questionnaire (Bristol Stool Scale and questions about fecal incontinence, and stool quality and frequency).
|Study Type :||Observational|
|Actual Enrollment :||402 participants|
|Official Title:||Multicenter Study of Patient-reported Gastrointestinal Symptoms in People With Cystic Fibrosis (GALAXY-OB-18)|
|Actual Study Start Date :||May 1, 2019|
|Actual Primary Completion Date :||September 17, 2019|
|Actual Study Completion Date :||September 17, 2019|
Subjects with a diagnosis of Cystic Fibrosis (CF) who meet all the inclusion and none of the exclusion criteria will be eligible for participation in this study.
- Percentage of completed assessments [ Time Frame: 1 month ]Percentage of scheduled outside-the-clinic assessments with at least one of the four PROs fully completed.
- Prevalence of Constipation [ Time Frame: 1 month ]Percentage of enrolled subjects with any occurrence of protocol-defined constipation during 1 month of follow-up (the period prevalence)
- Mean Patient Reported Outcome (PRO) Scores [ Time Frame: At Visit 1 (1 day) ]Mean PRO scores (PAC-SYM score range: 0-4, PAGI-SYM score range: 0-5, PAC-QOL score range: 0-4) at time of enrollment (Visit 1) where lower scores correspond to less symptom severity.
- Percentage of subjects treated for GI symptoms [ Time Frame: At Visit 1 (1 day) ]Percentage of enrolled subjects receiving treatment for GI symptoms at Visit 1
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): NCT03801993
|Principal Investigator:||A. Jay Freeman, MD, MSc||Emory University/Children's Healthcare|
|Principal Investigator:||Baharak Moshiree, MD||University of North Carolina Charlotte, Atrium Health|
|Principal Investigator:||Meghana Sathe, MD||University of Texas Southwestern/Children's Health|