Not provided
Not provided
Not provided
Not provided
low enrollment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Researchers are assessing the safety and effectiveness of antihistamines in the treatment of eosinophilic esophagitis.
The purpose of this research is to determine if antihistamines are safe and effective for the treatment of eosinophilic esophagitis. Antihistamines are frequently used for the treatment of gastroesophageal reflux disease and allergic disorders, and we hypothesize they will be effective in the treatment of eosinophilic esophagitis as well. The two antihistamines used in this study are loratadine and famotidine.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Participants receive Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks. |
|
| Placebo Group | Placebo Comparator | Participants receive Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famotidine | Drug | 40 mg tab twice daily by mouth for 12 week duration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of adverse events reported | 12 weeks |
| Change in Maximum Eosinophil Count | Calculated by maximum eosinophils per esophagogastroduodenoscopy (EGD) high-power field (eos/hpf) after therapy with antihistamines. As measured by the percentage of change in maximum eosinophil count from baseline to 12 weeks. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Symptoms of Eosinophilic Esophagitis, as Measured by Dysphagia Symptom Questionnaire | Measured by the self-reported Dysphagia Symptom Questionnaire (DSQ). The DSQ ranges from 0 to 10, with a lower score indicating less symptoms and a higher score indicating more symptoms. | 12 weeks |
| Change in Endoscopic Response, as Measured by the Endoscopic Reference Score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dawn Francis, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | Participants received Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks. Famotidine: 40 mg tab twice daily by mouth for 12 week duration Loratadine: 10 mg tab once daily by mouth for 12 week duration |
| FG001 | Placebo Group | Participants received Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks. Placebo: Contains no active ingredient |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Terminated study due to low enrollment. No subjects enrolled in the Placebo group
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | Participants received Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks. Famotidine: 40 mg tab twice daily by mouth for 12 week duration Loratadine: 10 mg tab once daily by mouth for 12 week duration |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events | Number of adverse events reported | Terminated study due to low enrollment. Data collection & analysis of Treatment group only. No subjects enrolled in the Placebo group | Posted | Number | adverse events | 12 weeks |
|
Adverse Events were collected from baseline to end of study, approximately 12 weeks
Terminated study due to low enrollment. No subjects enrolled in the Placebo group
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Participants received Famotidine 40 mg tab twice daily by mouth and Loratadine 10 mg tab once daily by mouth for 12 weeks. Famotidine: 40 mg tab twice daily by mouth for 12 week duration Loratadine: 10 mg tab once daily by mouth for 12 week duration |
Not provided
Not provided
Terminated study due to low enrollment. No subjects enrolled in the Placebo group
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Francis, M.D. | Mayo Clinic | 904-953-2254 | Francis.Dawn@mayo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2019 | Nov 14, 2022 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D057765 | Eosinophilic Esophagitis |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015738 | Famotidine |
| D017336 | Loratadine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Loratadine |
| Drug |
10 mg tab once daily by mouth for 12 week duration |
|
| Placebo | Drug | Contains no active ingredient |
|
Percentage of subjects with endoscopic response as measured by the Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS). The score ranges from 0 to 10, with a higher score indicating worse endoscopic findings of eosinophilic esophagitis. |
| 12 weeks |
| Change in Histologic Response | Percentage of subjects with histologic response of ≤15 eos/hpf on biopsy at the lower and mid esophagus | 12 weeks |
Participants received Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks. Placebo: Contains no active ingredient |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Change in Maximum Eosinophil Count | Calculated by maximum eosinophils per esophagogastroduodenoscopy (EGD) high-power field (eos/hpf) after therapy with antihistamines. As measured by the percentage of change in maximum eosinophil count from baseline to 12 weeks. | Terminated study due to low enrollment. No subjects enrolled in the Placebo group | Posted | Number | percentage change | 12 weeks |
|
|
|
| Secondary | Change in Symptoms of Eosinophilic Esophagitis, as Measured by Dysphagia Symptom Questionnaire | Measured by the self-reported Dysphagia Symptom Questionnaire (DSQ). The DSQ ranges from 0 to 10, with a lower score indicating less symptoms and a higher score indicating more symptoms. | Terminated study due to low enrollment. Data was not collected nor analyzed. No subjects enrolled in the Placebo group | Posted | 12 weeks |
|
|
| Secondary | Change in Endoscopic Response, as Measured by the Endoscopic Reference Score | Percentage of subjects with endoscopic response as measured by the Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS). The score ranges from 0 to 10, with a higher score indicating worse endoscopic findings of eosinophilic esophagitis. | Terminated study due to low enrollment. Data was not collected nor analyzed. No subjects enrolled in the Placebo group | Posted | 12 weeks |
|
|
| Secondary | Change in Histologic Response | Percentage of subjects with histologic response of ≤15 eos/hpf on biopsy at the lower and mid esophagus | Terminated study due to low enrollment. Data was not collected nor analyzed. No subjects enrolled in the Placebo group | Posted | 12 weeks |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Placebo Group | Participants received Famotidine placebo tablet matching Famotidine orally twice daily for 12 weeks, and Loratadine placebo tablet matching Loratadine orally daily for 12 weeks. Placebo: Contains no active ingredient | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| D005759 |
| Gastroenteritis |
| D004802 | Eosinophilia |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010880 | Piperidines |
| D011083 | Polycyclic Compounds |