DyspepsiaPhase 2NCT00303264
The Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.
A Phase 2 study testing dexloxiglumide and Nexium (esomeprazole) in people with Dyspepsia, run by Forest Laboratories at 1 site in United States.
Trial summary
"Functional dyspepsia" has been defined loosely as "pain or discomfort centered in the upper abdomen." The symptoms can also include fullness, early satiety, bloating, belching, nausea, retching and vomiting. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyspepsia
- What is being tested?
- dexloxiglumide and Nexium (esomeprazole)
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Aug 2007
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be male or female, 18 to 75 years of age, inclusive.
- Must understand English and be able to follow the instructions about completing the diary and questionnaires.
- At the time of Screening, have pain and/or discomfort in your upper abdomen for at least one day each week in the last month.
- At the time of Screening, have at least one other symptom of FD for at least one day each week in the last month.
Who cannot join
- Have a known hypersensitivity to dexloxiglumide, any PPI, or aluminum/magnesium-containing antacids
- Have a history of organic diseases, structural or biochemical, of the gastrointestinal system that can cause dyspepsia.
- Have active irritable bowel syndrome (C-IBS, alt-IBS, D-IBS).
- Have findings leading to a clinical suspicion of other secondary causes of dyspepsia, including endocrine, metabolic and neurological disorders.
- Have a body mass (BMI) value of greater than 38 (applies to both males and females).
- Have been enrolled in a previous investigational study of dexloxiglumide.
- Have received treatment with any investigational drug within a 30-day period, or 5 half-lives, whichever is longer, prior to study entry.
- Use or dependence on "prohibited" medications at study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
For information regarding investigative sites please contact Forest Professional Affairs
St Louis, Missouri, 63045
About this study
Official title: A Phase II Study to Investigate the Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.
"Functional dyspepsia" has been defined loosely as "pain or discomfort centered in the upper abdomen." The symptoms can also include fullness, early satiety, bloating, belching, nausea, retching and vomiting. These symptoms may present with or without the co-existence of symptoms of heartburn or gastroesophageal reflux disease (GERD). Functional dyspepsia is a diagnosis of exclusion in which other disease states, such as ulcer, cancer, etc. are ruled out and the source of the pain is unknown.
The standard of care for most patients presenting with dyspeptic symptoms has been with proton pump inhibitors (PPI), regardless of whether or not the patient's symptoms include acid-related conditions, e.g., heartburn, GERD, etc. Although PPI treatment has yielded some success in these patients, there is a significant population of patients whose dyspeptic symptoms are not adequately treated with PPI's alone.
The purpose of this study is to evaluate the use of dexloxiglumide in the treatment of the symptoms of functional dyspepsia in patients whose dyspeptic symptoms are not being treated adequately with PPI's.
- Conditions
- Dyspepsia
- Being tested
- dexloxiglumide, Nexium (esomeprazole)
- Keywords
- functional dyspepsia, cholecystokinin, CCK, gastrointestinal, intestinal transit, GI motility, bloating, upper GI discomfort, upper GI, early satiety, nausea, belching, retching, vomiting, GERD
- Medical subject headings
- Dyspepsia, Nausea, Eructation, Vomiting, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexloxiglumideDrug
Nexium (esomeprazole)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in (upper GI) pain/discomfort intensity.
Secondary outcomes (1)
Change from baseline in (upper GI) non-pain symptoms.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2006 (estimated)
- Study startMay 2006
- Primary completionAug 2007
- Study completionAug 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303264
- Sponsor's protocol ID
- DEX-MD-20
- Status last verified
- Mar 2012
- First submitted
- 14 Mar 2006
- Last updated
- 5 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Investigate the Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.
- ClinicalTrials.gov ID
- NCT00303264
- Acronym / sponsor ID
- DEX-MD-20
- Conditions
- Dyspepsia
- Keywords
- functional dyspepsia, cholecystokinin, CCK, gastrointestinal, intestinal transit, GI motility, bloating, upper GI discomfort
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 16 Mar 2006 (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.
"Functional dyspepsia" has been defined loosely as "pain or discomfort centered in the upper abdomen." The symptoms can also include fullness, early satiety, bloating, belching, nausea, retching and vomiting. These symptoms may present with or without the co-existence of symptoms of heartburn or gastroesophageal reflux disease (GERD). Functional dyspepsia is a diagnosis of exclusion in which other disease states, such as ulcer, cancer, etc. are ruled out and the source of the pain is unknown.
The standard of care for most patients presenting with dyspeptic symptoms has been with proton pump inhibitors (PPI), regardless of whether or not the patient's symptoms include acid-related conditions, e.g., heartburn, GERD, etc. Although PPI treatment has yielded some success in these patients, there is a significant population of patients whose dyspeptic symptoms are not adequately treated with PPI's alone.
The purpose of this study is to evaluate the use of dexloxiglumide in the treatment of the symptoms of functional dyspepsia in patients whose dyspeptic symptoms are not being treated adequately with PPI's.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be male or female, 18 to 75 years of age, inclusive.
- Must understand English and be able to follow the instructions about completing the diary and questionnaires.
- At the time of Screening, have pain and/or discomfort in your upper abdomen for at least one day each week in the last month.
- At the time of Screening, have at least one other symptom of FD for at least one day each week in the last month.
Key exclusion criteria (8 listed)
- Have a known hypersensitivity to dexloxiglumide, any PPI, or aluminum/magnesium-containing antacids
- Have a history of organic diseases, structural or biochemical, of the gastrointestinal system that can cause dyspepsia.
- Have active irritable bowel syndrome (C-IBS, alt-IBS, D-IBS).
- Have findings leading to a clinical suspicion of other secondary causes of dyspepsia, including endocrine, metabolic and neurological disorders.
- Have a body mass (BMI) value of greater than 38 (applies to both males and females).
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 |
|---|---|---|
| dexloxiglumide | Drug | – |
| Nexium (esomeprazole) | Drug | – |
Primary outcome
Change from baseline in (upper GI) pain/discomfort intensity.
1 secondary outcome
Change from baseline in (upper GI) non-pain symptoms.
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 5 Mar 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dexloxiglumide and Nexium (esomeprazole) in people with Dyspepsia, run by Forest Laboratories at 1 site in United States.
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 8 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 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in (upper GI) pain/discomfort intensity.. 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 5 Mar 2012.