NCT01043185

Brief Summary

The purpose of the study is to estimate what effect 4 different doses of AZD3355 will have on the number of reflux episodes, in patients who have GERD and still experience symptoms despite proton pump inhibitor (PPI) treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_2

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

December 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 14, 2011

Completed
Last Updated

June 14, 2011

Status Verified

May 1, 2011

Enrollment Period

5 months

First QC Date

December 22, 2009

Results QC Date

April 8, 2011

Last Update Submit

May 13, 2011

Conditions

Gastroesophageal Reflux Disease

Keywords

GERDlesogaberanimpedancepHpharmacokineticssafetytolerability

Outcome Measures

Primary Outcomes (1)

  • Total Number of Reflux Episodes During 24 Hours

    Number of reflux episodes assessed during ambulatory impedance-pH recording (defined as starting with a drop in impedance to below 50% of baseline and ending when impedance recovers to above 50% of baseline)

    Measured during 24 hours at 4 different visits with a 7-28 days interval between

Secondary Outcomes (3)

  • Number of Acid Reflux Episodes

    Measured during 24 hours at 4 different visits with a 7-28 days interval between

  • Number of Weakly Acidic Reflux Episodes

    Measured during 24 hours at 4 different visits with a 7-28 days interval between

  • Number of Weakly Alkaline Reflux Episodes

    Measured during 24 hours at 4 different visits with a 7-28 days interval between

Study Arms (5)

A

EXPERIMENTAL

AZD3355 30 mg

Drug: AZD3355

B

EXPERIMENTAL

AZD3355 90 mg

Drug: AZD3355

C

EXPERIMENTAL

AZD3355 120 mg

Drug: AZD3355

D

EXPERIMENTAL

AZD3355 240 mg

Drug: AZD3355

E

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

AZD3355DRUG

30 mg orally in the morning and 30 mg in the evening for 1 day

A
placeboDRUG

Placebo capsules orally in the morning and placebo capsules in the evening for 1 day

E

Eligibility Criteria

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

You may qualify if:

  • Provide informed consent
  • History of GERD with persistent symptoms despite treatment with PPI
  • Otherwise normal physical health

You may not qualify if:

  • History of GERD with symptoms that has not improved at all during treatment with PPI
  • Prior surgery of the upper gastrointestinal tract
  • History of significant heart disease, cardiovascular, respiratory, hepatic, renal, metabolic, psychiatric or gastrointestinal disorders besides GERD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Oklahoma City, Oklahoma, United States

Location

Related Publications (1)

  • Miner PB Jr, Silberg DG, Ruth M, Miller F, Pandolfino J. Dose-dependent effects of lesogaberan on reflux measures in patients with refractory gastroesophageal reflux disease: a randomized, placebo-controlled study. BMC Gastroenterol. 2014 Nov 18;14:188. doi: 10.1186/1471-230X-14-188.

    PMID: 25407279DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

lesogaberan

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
ClinicalTrialTransparency@astrazeneca.com

Study Officials

  • Philip Miner

    Oklahoma Foundation of Digestive Research

    PRINCIPAL INVESTIGATOR

  • Debra G Silberg

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 22, 2009

First Posted

January 6, 2010

Study Start

December 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 14, 2011

Results First Posted

June 14, 2011

Record last verified: 2011-05

Locations

US(1)