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Histamine H2 Receptor Antagonist

Cimetidine for Protoporphyria

Phase 2
Recruiting
Led By Amy K Dickey, MD
Research Sponsored by Amy K. Dickey, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female age ≥15 years at screening
Prior enrollment or co-enrollment in the Longitudinal Study of the Porphyrias (PC Study 7201) with a confirmed diagnosis of EPP or XLP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before and after each 3-month treatment period
Awards & highlights

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.

Who is the study for?
This trial is for individuals at least 15 years old with a confirmed diagnosis of Erythropoietic Protoporphyria (EPP) or X-linked Protoporphyria (XLP), who have a history of skin sensitivity to light but are not using other experimental therapies. Participants must be willing to use their smartphone for the study and expose themselves to light weekly.Check my eligibility
What is being tested?
The trial is testing if oral Cimetidine can treat protoporphyrias by reducing protoporphyrin levels, improving tolerance to light, and enhancing quality of life. It's compared against a placebo, with outcomes measured through questionnaires and blood tests.See study design
What are the potential side effects?
Cimetidine may cause side effects such as headaches, dizziness, gastrointestinal issues like diarrhea or constipation, tiredness, and in rare cases more serious reactions like heart rhythm problems or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 15 years old or older.
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I am diagnosed with EPP or XLP and enrolled in the PC Study 7201.
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I am willing and able to follow the study's procedures and give informed consent.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before and after each 3-month treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after each 3-month treatment period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Erythrocyte total protoporphyrin level
Secondary outcome measures
Light dose
Patient-reported quality of life
Phototoxic episodes
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: CimetidineActive Control1 Intervention
Cimetidine 800mg orally twice daily
Group II: PlaceboPlacebo Group1 Intervention
Placebo capsule orally twice daily

Find a Location

Who is running the clinical trial?

University of TexasOTHER
187 Previous Clinical Trials
142,433 Total Patients Enrolled
Amy K. Dickey, M.D.Lead Sponsor
Wake Forest University Health SciencesOTHER
1,240 Previous Clinical Trials
1,004,187 Total Patients Enrolled

Media Library

Cimetidine (Histamine H2 Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05020184 — Phase 2
Erythropoietic Protoporphyria Research Study Groups: Placebo, Cimetidine
Erythropoietic Protoporphyria Clinical Trial 2023: Cimetidine Highlights & Side Effects. Trial Name: NCT05020184 — Phase 2
Cimetidine (Histamine H2 Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05020184 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effect of Oral Cimetidine in the Protoporphyrias
Amy K. Dickey, M.D. 2022. "Effect of Oral Cimetidine in the Protoporphyrias". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05020184.
~6 spots leftby Feb 2025
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