NCT00115362

Brief Summary

The purpose of this study is to investigate whether Efexor (venlafaxine) is effective in the treatment of functional dyspepsia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2005

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

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

First Submitted

Initial submission to the registry

June 21, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 22, 2005

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

September 24, 2007

Status Verified

September 1, 2007

First QC Date

June 21, 2005

Last Update Submit

September 21, 2007

Conditions

Dyspepsia

Keywords

functional dyspepsia;Serotonin Uptake Inhibitors;Antidepressive Agents.

Outcome Measures

Primary Outcomes (1)

  • Upper gastrointestinal symptom absence after 6 weeks treatment.

Secondary Outcomes (3)

  • Anxiety and depression after venlafaxine treatment

  • Health related quality of life after venlafaxine treatment

  • The association between serotonin transporter protein and 5-HT receptor polymorphisms and efficacy of venlafaxine.

Interventions

venlafaxineDRUG

Eligibility Criteria

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

You may qualify if:

  • Persistent upper gastrointestinal symptoms;
  • Absence of any serious organic cause of the complaints at previous upper gastrointestinal endoscopy (including gastric ulcer, carcinoma, oesophageal reflux disease, portal hypertension, hernia hiatus \>2 cm or severe gastritis);
  • Over 18 years of age;
  • Written informed consent.

You may not qualify if:

  • History of bipolar disorder;
  • Contra-indication for venlafaxine;
  • Current or planned pregnancy or lactation;
  • Diagnosed alcoholism, anorexia nervosa or bulimia;
  • Current or recent (within the last two weeks) use of a selective serotonin re-uptake inhibitor (SSRI) or MAO-inhibitor;
  • Any other condition or circumstance that, in the opinion of the investigator or the physician, would compromise the subject's successful participation in this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Radboud University Nijmegen Medical Center

Nijmegen, P.O. Box 9101, 6500 HB, Netherlands

Location

Rijnstate Hospital

Arnhem, Netherlands

Location

Slingeland Hospital

Doetinchem, Netherlands

Location

Gelderse Vallei Hospital

Ede, Netherlands

Location

Canisius-Wilhelmina Hospital

Nijmegen, 6500 GS, Netherlands

Location

Bernhoven hospital

Oss, Netherlands

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Study Officials

  • Jan Jansen, Professor MD

    Radboud University Nijmegen Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 21, 2005

First Posted

June 22, 2005

Study Start

July 1, 2005

Study Completion

July 1, 2007

Last Updated

September 24, 2007

Record last verified: 2007-09

Locations

NL(6)