NCT00182260

Brief Summary

LNF is an effective intervention in the management of patients with chronic GERD requiring maintenance therapy. LNF is cost-effective compared with long-term medical therapy. LNF is more effective than maximum medical therapy in control of respiratory symptoms and complications of GERD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
216

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

November 15, 2012

Status Verified

November 1, 2012

Enrollment Period

10.3 years

First QC Date

September 12, 2005

Last Update Submit

November 14, 2012

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (3)

  • GERD Symptom Scale

  • Symptom-free Day Measurement

  • Cost Measurement

Secondary Outcomes (7)

  • 24-hour pH

  • Economic Analysis

  • Endoscopy

  • Esophageal manometry

  • Health related quality of life (SF-36)

  • +2 more secondary outcomes

Study Arms (2)

Proton Pump Inhibitor

ACTIVE COMPARATOR

Patients randomized to medical therapy received optimized treatment with PPI using a standardized management protocol based on best evidence and published guidelines.

Drug: Proton Pump Inhibitors

Laparoscopic Nissen Fundoplication

ACTIVE COMPARATOR

Surgical patients underwent LNF using previously published technique.

Procedure: Laparoscopic Nissen Fundoplication

Interventions

Proton Pump InhibitorsDRUG
Proton Pump Inhibitor
Laparoscopic Nissen FundoplicationPROCEDURE
Laparoscopic Nissen Fundoplication

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female GERD patients aged 18-70 years with GERD symptoms.
  • Prior long-term treatment with PPI with minimum duration of 1 year with expected future duration of at least 2 more years.
  • Controlled on 20-40mg/day maintenance PPI therapy prior to study, defined as GERD symptom score\<18 and score of 70 or more on 1-100 Global Rating Scale at screening (on medication).
  • Increase in GERD symptom score\>=15 points at baseline (off omeprazole).
  • GERD symptom score\>=18 at baseline (off omeprazole).
  • Percent acid reflux in 24hr 4% at baseline (off omeprazole).
  • Positive Bernstein test at baseline.
  • Willingness to adhere to randomized treatment with availability for 3 years of follow-up.
  • Ability to answer self and interviewer-administered questions in English.
  • Signed informed consent.

You may not qualify if:

  • Aperistaltic esophagus.
  • Severe cardiac, respiratory, hematologic or other disease constituting an unacceptable surgical risk in the investigator's opinion.
  • Previous gastric, esophageal or anti-reflux surgery.
  • History of malignancy within the last year with the exception of basal cell carcinoma.
  • Pregnancy or an intention to become pregnant in the following year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Proton Pump Inhibitors

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Enzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Mehran Anvari, MB, BS, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

  • David Armstrong, MB, BCh, MA

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Charles H. Goldsmith, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

January 1, 2000

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

November 15, 2012

Record last verified: 2012-11

Locations

CA(1)