Trial Outcomes & Findings for Antihistamines in Eosinophilic Esophagitis (NCT NCT04248712)

NCT ID: NCT04248712

Last Updated: 2022-12-20

Results Overview

Number of adverse events reported

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

12 weeks

Results posted on

2022-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Antihistamines in Eosinophilic Esophagitis

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 12 weeks

Population: Terminated study due to low enrollment. Data collection \& analysis of Treatment group only. No subjects enrolled in the Placebo group

Number of adverse events reported

Outcome measures

Outcome measures
Measure	Treatment Group n=1 Participants 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	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
Adverse Events	0 adverse events	—

PRIMARY outcome

Timeframe: 12 weeks

Population: Terminated study due to low enrollment. No subjects enrolled in the Placebo group

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.

Outcome measures

Outcome measures
Measure	Treatment Group n=1 Participants 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	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
Change in Maximum Eosinophil Count	0 percentage change	—

SECONDARY outcome

Timeframe: 12 weeks

Population: Terminated study due to low enrollment. Data was not collected nor analyzed. No subjects enrolled in the Placebo group

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Terminated study due to low enrollment. Data was not collected nor analyzed. No subjects enrolled in the Placebo group

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Terminated study due to low enrollment. Data was not collected nor analyzed. No subjects enrolled in the Placebo group

Percentage of subjects with histologic response of ≤15 eos/hpf on biopsy at the lower and mid esophagus

Outcome measures

Outcome data not reported

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dawn Francis, M.D.

Mayo Clinic

Phone: 904-953-2254

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treatment Group n=1 Participants 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	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	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants