DyspepsiaNCT00115362
Serotonin Effect in Functional Dyspepsia
A study testing venlafaxine in people with Dyspepsia, run by Radboud University Medical Center at 6 sites in Netherlands.
Trial summary
The purpose of this study is to investigate whether Efexor (venlafaxine) is effective in the treatment of functional dyspepsia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspepsia
- What is being tested?
- venlafaxine
- How many people
- 300 participants
- Where
- 6 sitesNetherlands
- Study dates
- Jul 2005to Jul 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Rijnstate Hospital
Arnhem
Slingeland Hospital
Doetinchem
Gelderse Vallei Hospital
Ede
Radboud University Nijmegen Medical Center
Nijmegen, P.O. Box 9101, 6500 HB
Canisius-Wilhelmina Hospital
Nijmegen, 6500 GS
Bernhoven hospital
Oss
About this study
Official title: Serotonin Effect in Non-Ulcer Dyspepsia
The purpose of this study is to investigate whether Efexor (venlafaxine) is effective in the treatment of functional dyspepsia.
Read the detailed description
BACKGROUND: A good 60% of patients presenting with upper abdominal complaints have functional dyspepsia. Usually, acid-suppressive drugs are given as first-line therapy for upper gastrointestinal symptoms. However, results are often not satisfying and symptoms persist. Since many patients with functional gastrointestinal diseases are more anxious and depressed in comparison to healthy controls, several studies investigated the use of antidepressant agents in these patients. Although many studies were underpowered, promising results were obtained with tricyclic antidepressant and mianserin in patients with irritable bowel syndrome. There is still a need for a placebo controlled study with antidepressants in patients with functional dyspepsia.
OBJECTIVE: To investigate the effectiveness of venlafaxine, a selective serotonin and norepinephrine reuptake inhibitor, for treatment of patients with functional dyspepsia.
STUDY DESIGN: A randomized, double blind, placebo controlled trial.
STUDY POPULATION: Consecutive patients with persistent upper GI symptoms without abnormalities at upper gastrointestinal endoscopy.
PRIMARY ENDPOINTS: Upper gastrointestinal symptom absence after 6 weeks treatment.
SECONDARY ENDPOINTS:
- 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.
STUDY PROCEDURE: A venous blood sample will be collected in a 10ml EDTA-tube. Then, each subject will be randomized to treatment with Efexor XR (first and last two weeks 75 mg 1dd and from the third to the fifth week 75 mg 2dd) or identical placebos for 8 weeks. Before starting and after finishing treatment, patients will be asked to fill out a questionnaire on intensity of their gastrointestinal complaints, current quality of life and anxiety and depression.
- Conditions
- Dyspepsia
- Being tested
- venlafaxine
- Keywords
- functional dyspepsia;, Serotonin Uptake Inhibitors;, Antidepressive Agents.
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venlafaxineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2005 (estimated)
- Study startJul 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jan Jansen, Professor MD, Study director, Radboud University Nijmegen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115362
- Sponsor's protocol ID
- SEREIN
- Status last verified
- Sep 2007
- First submitted
- 21 Jun 2005
- Last updated
- 24 Sep 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotonin Effect in Non-Ulcer Dyspepsia
- ClinicalTrials.gov ID
- NCT00115362
- Acronym / sponsor ID
- SEREIN
- Conditions
- Dyspepsia
- Keywords
- functional dyspepsia;, Serotonin Uptake Inhibitors;, Antidepressive Agents.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 22 Jun 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate whether Efexor (venlafaxine) is effective in the treatment of functional dyspepsia.
Detailed description
BACKGROUND: A good 60% of patients presenting with upper abdominal complaints have functional dyspepsia. Usually, acid-suppressive drugs are given as first-line therapy for upper gastrointestinal symptoms. However, results are often not satisfying and symptoms persist. Since many patients with functional gastrointestinal diseases are more anxious and depressed in comparison to healthy controls, several studies investigated the use of antidepressant agents in these patients. Although many studies were underpowered, promising results were obtained with tricyclic antidepressant and mianserin in patients with irritable bowel syndrome. There is still a need for a placebo controlled study with antidepressants in patients with functional dyspepsia.
OBJECTIVE: To investigate the effectiveness of venlafaxine, a selective serotonin and norepinephrine reuptake inhibitor, for treatment of patients with functional dyspepsia.
STUDY DESIGN: A randomized, double blind, placebo controlled trial.
STUDY POPULATION: Consecutive patients with persistent upper GI symptoms without abnormalities at upper gastrointestinal endoscopy.
PRIMARY ENDPOINTS: Upper gastrointestinal symptom absence after 6 weeks treatment.
SECONDARY ENDPOINTS:
- 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.
STUDY PROCEDURE: A venous blood sample will be collected in a 10ml EDTA-tube. Then, each subject will be randomized to treatment with Efexor XR (first and last two weeks 75 mg 1dd and from the third to the fifth week 75 mg 2dd) or identical placebos for 8 weeks. Before starting and after finishing treatment, patients will be asked to fill out a questionnaire on intensity of their gastrointestinal complaints, current quality of life and anxiety and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venlafaxine | Drug | – |
Primary outcome
Upper gastrointestinal symptom absence after 6 weeks treatment.
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Jansen, Professor MD study director
Radboud University Nijmegen Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing venlafaxine in people with Dyspepsia, run by Radboud University Medical Center at 6 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper gastrointestinal symptom absence after 6 weeks treatment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2007.