NCT02232308

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

June 23, 2014

Last Update Submit

April 28, 2015

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (2)

  • Change in plasma heme oxygenase 1 (HO-1) protein concentration

    Heme oxygenase (HO-1) degrades heme and protects against oxidative stress. HO-1 concentration was measured by a blood test; the units are ng/ml.

    Day 3, Day 10

  • Change in Monocyte HO-1 activity

    Heme oxygenase (HO-1) degrades heme and protects against oxidative stress. When HO-1 is induced, more heme is removed, and end products of heme metabolism (i.e., carbon monoxide, iron, and bilirubin) are generated. HO-1 activity was measured by a blood test, the units are pmol bilirubin/mg/h.

    Day 3, Day 10

Study Arms (4)

Nizatidine

EXPERIMENTAL

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.

Drug: Nizatidine

Lisinopril

EXPERIMENTAL

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.

Drug: Lisinopril

Nizatidine plus Lisinopril

EXPERIMENTAL

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.

Drug: NizatidineDrug: Lisinopril

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

NizatidineDRUG

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.

Also known as: Axid
NizatidineNizatidine plus Lisinopril
LisinoprilDRUG

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.

Also known as: Zestril, Prinivil
LisinoprilNizatidine plus Lisinopril
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy subjects without clinical evidence of significant cardiovascular, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns
  • Normal serum potassium and estimated glomerular filtration rate (eGFR) \> 60 ml/minute
  • Baseline systolic BP ≥ 110 mmHg
  • No known hypersensitivity to lisinopril or nizatidine
  • Able to provide written informed consent before participating in the study
  • Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

You may not qualify if:

  • Pregnant
  • Breast feeding
  • Current smoker
  • Symptoms of functional GI disorder as assessed by a validated questionnaire
  • Previous history of peptic ulcer disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Gastroparesis

Interventions

NizatidineLisinopril

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Adil Bharucha, MBBS, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

June 23, 2014

First Posted

September 5, 2014

Study Start

July 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 30, 2015

Record last verified: 2015-04

Locations

US(2)