NCT00564590

Brief Summary

We hypothesize that melatonin as compared to PPI and to placebo, improves GERD symptoms by decreasing esophageal acid exposure and esophageal acid sensitivity in GERD. We hypothesize that melatonin as compared to PPI and to placebo reduce the frequency and duration of transient lower esophageal sphincter relaxations (TLESRs). In addition we hypothesize that melatonin as compared to PPI and to placebo improves quality of life and quality of sleep of GERD patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

November 26, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 28, 2007

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

November 28, 2007

Status Verified

November 1, 2007

First QC Date

November 26, 2007

Last Update Submit

November 26, 2007

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

  • This study will test the efficacy of melatonin (10 mg once a day) as compared to standard dose PPI (omeprazole 20 mg once a day) and placebo on different subjective and objective parameters of 150 patients with GERD.

    3 years

Secondary Outcomes (1)

  • To determine the effect of melatonin versus standard-dose PPI versus placebo on frequency and duration of TLESRs.

    3 years

Study Arms (3)

A

EXPERIMENTAL

Melatonin treatment group

Drug: Melatonin

B

ACTIVE COMPARATOR

Omeprazole 20 mg once a day for 3 months

Other: omeprazole

C

EXPERIMENTAL

Placebo once a day for 3 months

Drug: Placebo

Interventions

MelatoninDRUG

4 mg of Melatonin once a day for 3 months

A
omeprazoleOTHER

omeprazole 20 mg once a day

Also known as: Omepradex
B
PlaceboDRUG

Placebo once a day

C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18-75.
  • Male or female.
  • GERD symptoms at least twice a week for the last three months.
  • Able to read, understand and complete study questionnaires and diary
  • Understand the study procedures and sign written informed consent.
  • Able to comply with all study requirements.

You may not qualify if:

  • Subjects with erosive esophagitis (EE), Barrett's esophagus (BE) and esophageal stricture or adenocarcinoma on upper endoscopy.
  • Subjects with previous upper gastrointestinal surgery.
  • Subjects with clinically significant medical conditions (cardiovascular, respiratory, renal, hepatic, hematologic, endocrine, neurologic and psychiatric); examples as follows: liver cirrhosis, severe COPD, severe renal failure, severe heart failure, active malignancy.
  • Subjects requiring narcotics (morphine, methadone, etc.).
  • Subjects requiring melatonin
  • Subjects with diabetes, scleroderma and neuromuscular disorders.
  • Lactating or pregnant women.
  • Subjects with an unrecognized lifestyle such as shift workers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center, Beilinson Hospital

Petah Tikva, 49100, Israel

Location

Related Publications (1)

  • Pereira Rde S. Regression of gastroesophageal reflux disease symptoms using dietary supplementation with melatonin, vitamins and aminoacids: comparison with omeprazole. J Pineal Res. 2006 Oct;41(3):195-200. doi: 10.1111/j.1600-079X.2006.00359.x.

    PMID: 16948779BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

MelatoninOmeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingBenzimidazoles

Study Officials

  • Ram M Dickman, MD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ram M Dickman, MD

CONTACT

03:9377236dickmanr@clalit.org.il

Tami Lederfine

CONTACT

03:9377040Tamila@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 26, 2007

First Posted

November 28, 2007

Study Start

October 1, 2008

Study Completion

January 1, 2011

Last Updated

November 28, 2007

Record last verified: 2007-11

Locations

IL(1)