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Nizatidine for Delayed Gastric Emptying

Phase 1
Waitlist Available
Led By Adil Bharucha, MBBS, MD
Research Sponsored by Adil Bharucha
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 3, day 10
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved

Summary

To assess if oral nizatidine or lisinopril alone and in combination will increase heme oxygenase 1 (HO-1) protein concentration and activity compared to placebo in healthy subjects.

Eligible Conditions
  • Delayed Gastric Emptying
  • Gastroparesis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 3, day 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 3, day 10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Monocyte HO-1 activity
Change in plasma heme oxygenase 1 (HO-1) protein concentration

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Nizatidine plus LisinoprilExperimental Treatment2 Interventions
Nizatidine (150 mg) and Lisinopril (10 mg) will be administered once daily for the first 3 days, then twice daily for days 4-9, and once on day 10.
Group II: NizatidineExperimental Treatment1 Intervention
Nizatidine (150 mg) will be administered once daily for the first 3 days, then twice daily for days 4-9, and once on day 10.
Group III: LisinoprilExperimental Treatment1 Intervention
Lisinopril (10 mg) will be administered once daily for the first 3 days, then twice daily for days 4-9, and once on day 10.
Group IV: PlaceboPlacebo Group1 Intervention
Placebo capsules to match active drug will be administered once daily for the first 3 days, then twice daily for days 4-9, and once on day 10.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nizatidine
FDA approved
Lisinopril
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Center for Research Resources (NCRR)NIH
539 Previous Clinical Trials
317,078 Total Patients Enrolled
Adil BharuchaLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,452 Previous Clinical Trials
4,332,615 Total Patients Enrolled
~2 spots leftby Nov 2025
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