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Cimetidine for Protoporphyria
Study Summary
This trial will determine if cimetidine is an effective and safe treatment for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), two conditions that cause lifelong pain sensitivity to light.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have high porphyrin levels due to liver or bone marrow disease.I am 15 years old or older.You have a known or suspected allergy or intolerance to cimetidine.I am pregnant, breastfeeding, or planning to become pregnant soon.I have moderate to severe problems with my kidneys.I am not taking any drugs or supplements that could affect my safety or the study's goals.I am not willing to expose myself to light until I start feeling initial symptoms.I am diagnosed with EPP or XLP and enrolled in the PC Study 7201.I have had a liver or bone marrow transplant or significant liver issues.I am willing and able to follow the study's procedures and give informed consent.You have a history of skin sensitivity to sunlight that does not cause blisters.I don't have a smartphone or won't use it for the study.I have not taken cimetidine in the last 3 months.
- Group 1: Placebo
- Group 2: Cimetidine
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many patients fit the screening criteria for this experiment?
"In order to carry out this research, 20 individuals who fit the given inclusion criteria are needed. These people can come from different locations, such as University of Texas Medical Branch in Galveston, Texas and Massachusetts General Hospital in Boston, Massachusetts."
Are we able to enroll new participants at this time?
"That is correct, the online information specifies that this study is still admitting patients. This trial was originally posted on June 14th, 2022 and has since had an update on August 10th, 2022. So far, 20 people have been recruited from 3 hospitals."
Is Cimetidine a common drug to test in medical trials?
"Cimetidine was first evaluated in a clinical setting at Ohio State University Comprehensive Cancer Center. Out of the 18,306 completed studies, there are only 2 that are currently ongoing. Both of these active trials are based out of Galveston, Texas."
What are some of the reasons that people take Cimetidine?
"The conditions of heartburn, zollinger-ellison syndrome, and nsaid use can all be remedied by Cimetidine."
What have been the most frequently reported side effects of Cimetidine?
"Cimetidine's safety is estimated to be a 2. This is because, although there are indications of safety in phase 2 trials, there is no data currently supporting efficacy."
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