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Observational Completed with Results
GI symptoms observational study (GALAXY) (GALAXY-OB-18)
This study required a single visit where participants enrolled in the study and took four questionnaires. Participants then took these questionnaires again at three different times remotely from outside the clinic. Researchers evaluated the results to learn about cystic fibrosis (CF) gastrointestinal (GI) symptoms and treatment.
This was an observational study looking at two age groups: adults (age ≥18 years) and 42% were children (age <18 years).
Eligibility
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Age:
2 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Study Results
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What We Learned:
This study established a baseline of GI symptoms in children and adults with CF. Of all participants, 98.3% were on a GI medication at enrollment. Pancreatic enzyme replacement therapy (PERT) was the most common medication (88.3%), followed by acid suppressive agents (60.2%), constipation medications (41.3%), and polyethylene glycol (PEG) as a laxative (37.1%).
Like other studies, this study confirmed an overall high prevalence of upper and lower GI symptoms in people with CF. The most common symptoms experienced were straining, fullness, incomplete bowel movements, bloating, distension, and lower and upper abdominal pain. This study found that these GI symptoms were more common in adults than in children and more prevalent in females. Participants reported a high overall dissatisfaction with existing therapies.
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Primary Findings:
Effectiveness:
N/A
N/A
Safety:
This study was conducted between May and August 2019 and enrolled 402 participants of whom 58% were adults (age ≥18 years) and 42% were children (age <18 years).
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Citation:
J Cyst Fibros 2023;22(2):266-274
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Clinical trials can be observational or interventional. In an observational study, participants are being observed while receiving routine care. In an interventional study, participants receive one or more treatments (interventions) or a placebo so that researchers can evaluate the effects on the participant’s health.
Observational -
Randomized Study: ?more info
A clinical trial in which participants are assigned by chance to one of two or more treatment arms.
No -
Placebo Controlled: ?more info
A clinical trial in which a drug is studied by giving an inactive substance (a placebo) to one group of participants, while the drug being tested is given to another.
No -
Length of Participation:
29 days -
Number of Study Visits:
1
Additional Information
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Phase: ?more info
The steps involved in development of new drugs. Phase I focuses on initial safety in people. Phase II studies evaluate safety, correct dose and early signs of drug effect. Phase III studies are the final large studies of safety and drug effectiveness before a drug can be reviewed for approval by the FDA. Phase IV studies evaluate a drug after it has been approved by the FDA.
Not Applicable -
Study Sponsor: ?more info
The company or organization that initiates and conducts the study.
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Study Drugs:
N/A
Eligibility
-
Age:
2 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
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