HealthyPhase 1/2NCT00370110
Effects of Itopride on Gastric Motor and Sensory Functions in Healthy Volunteers
A Phase 1/2 study testing Itopride 100 mg and Itopride 200 mg in people with Healthy, run by Forest Laboratories at 1 site in United States.
Trial summary
Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Itopride 100 mg and Itopride 200 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Nov 2005
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1.Non-pregnant, non-breastfeeding females 2.18 years of age or older 3.Body mass index between 20 and 32 kg/m2 4.No alarm indicators on clinical assessment (weight loss of more than 7 kg, bleeding, recent recurrent vomiting, progressive dysphagia).
- 5.No history suggestive of small bowel obstruction
Who cannot join
- Patients who have any gastrointestinal symptoms. Do not fulfill the criteria for the irritable bowel syndrome or functional dyspepsia clinically
- Patients with a clinical diagnosis of gastroparesis or an alternative underlying disease that could be responsible for disturbed gastric function e.g. diabetes, post-vagotomy, post-fundoplication
- Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, caesarian section or tubal ligation
- Positive symptoms on an abridged bowel disease questionnaire
- Use of medications that may alter gastrointestinal motility including metoclopramide, domperidone, tegaserod; acetaminophen and ibuprofen will be allowed
- Current use of medications which may interact with the study medications
Show all 11Show fewer
- Patients who have taken any investigational medications within the past 30 days
- Over the counter medication (except multivitamins) within 7 days of the study
- Chronic gastrointestinal illness or any systemic disease that could affect gastrointestinal motility for controls
- Known intolerance or allergy to eggs, milk and Ensure
- History of chronic diarrhea
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic College of Medicine
Rochester, Minnesota, 55905
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Single Center, Parallel Group Study to Evaluate the Effects of Itopride (100 mg and 200 mg t.i.d.) on Gastric Motor and Sensory Functions in Healthy Volunteers
Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis. Due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea and vomiting following ingestion of a meal. This is a randomized, parallel group, two dose double blind, placebo-controlled study evaluating the effects of itopride (100 mg and 200 mg three times daily) and placebo on gastric motor and sensory functions in healthy volunteers.
Read the detailed description
In order to compare the effects of two itopride doses (100 mg and 200 mg three times daily) and placebo on gastric emptying and small bowel transit, gastric accommodation, and postprandial symptoms in female and male healthy volunteers, the following methods, which have been extensively used and validated in the laboratory, will be used:
Scintigraphic gastric emptying of solids and small bowel transit; single photon emission computed tomography to measure gastric accommodation; and the nutrient drink test to measure maximum tolerated volume and postprandial symptoms.
Based on data acquired using the same methods in the laboratory, the sample size of 15 subjects per group provides 80% power to detect an effect size of 16% in the primary endpoint of the study, that is a change in gastric volume (postprandial - fasting). This magnitude of change is considered clinically relevant.
- Conditions
- Healthy
- Being tested
- Itopride 100 mg, Placebo, Itopride 200 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Itopride 100 mgDrug
100 mg three times daily
PlaceboOther
Itopride 200 mgDrug
200 mg three times daily
| Study group | Role | What they receive |
|---|---|---|
| Itopride | Experimental | Not described Receives: Drug: Itopride 100 mg; Drug: Itopride 200 mg |
| Placebo | Other | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying
Measured: one week
Secondary outcomes (3)
Small bowel transit
Measured: one week
Gastric accommodation
Measured: one week
Postprandial symptoms
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2006 (estimated)
- Study startAug 2005
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas J. Talley, M.D., Ph.D., Principal investigator, Mayo Clinic College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370110
- Sponsor's protocol ID
- ITODG04-02
- Status last verified
- Feb 2017
- First submitted
- 28 Aug 2006
- Last updated
- 9 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled, Single Center, Parallel Group Study to Evaluate the Effects of Itopride (100 mg and 200 mg t.i.d.) on Gastric Motor and Sensory Functions in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00370110
- Acronym / sponsor ID
- ITODG04-02
- Conditions
- Healthy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 30 Aug 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.
Itopride is a new compound that is already marketed in Japan and in some countries of Eastern Europe under the name of Ganaton. It is used to treat symptoms associated with gastroparesis. Due to inadequate gastric emptying, these patients often have symptoms of bloating, nausea and vomiting following ingestion of a meal. This is a randomized, parallel group, two dose double blind, placebo-controlled study evaluating the effects of itopride (100 mg and 200 mg three times daily) and placebo on gastric motor and sensory functions in healthy volunteers.
Detailed description
In order to compare the effects of two itopride doses (100 mg and 200 mg three times daily) and placebo on gastric emptying and small bowel transit, gastric accommodation, and postprandial symptoms in female and male healthy volunteers, the following methods, which have been extensively used and validated in the laboratory, will be used:
Scintigraphic gastric emptying of solids and small bowel transit; single photon emission computed tomography to measure gastric accommodation; and the nutrient drink test to measure maximum tolerated volume and postprandial symptoms.
Based on data acquired using the same methods in the laboratory, the sample size of 15 subjects per group provides 80% power to detect an effect size of 16% in the primary endpoint of the study, that is a change in gastric volume (postprandial - fasting). This magnitude of change is considered clinically relevant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Itopride | Experimental | Drug: Itopride 100 mg, Drug: Itopride 200 mg |
| Placebo | Other | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1.Non-pregnant, non-breastfeeding females 2.18 years of age or older 3.Body mass index between 20 and 32 kg/m2 4.No alarm indicators on clinical assessment (weight loss of more than 7 kg, bleeding, recent recurrent vomiting, progressive dysphagia).
- 5.No history suggestive of small bowel obstruction
Key exclusion criteria (11 listed)
- Patients who have any gastrointestinal symptoms. Do not fulfill the criteria for the irritable bowel syndrome or functional dyspepsia clinically
- Patients with a clinical diagnosis of gastroparesis or an alternative underlying disease that could be responsible for disturbed gastric function e.g. diabetes, post-vagotomy, post-fundoplication
- Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, caesarian section or tubal ligation
- Positive symptoms on an abridged bowel disease questionnaire
- Use of medications that may alter gastrointestinal motility including metoclopramide, domperidone, tegaserod; acetaminophen and ibuprofen will be allowed
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 |
|---|---|---|
| Itopride 100 mg100 mg three times daily | Drug | Itopride |
| Placebo | Other | Placebo |
| Itopride 200 mg200 mg three times daily | Drug | Itopride |
Primary outcome
Gastric emptying
Time frame: one week
3 secondary outcomes
Small bowel transit
Time frame: one week
Gastric accommodation
Time frame: one week
Postprandial symptoms
Time frame: one week
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 9 Feb 2017.
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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.
Nicholas J. Talley, M.D., Ph.D. principal investigator
Mayo Clinic College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Itopride 100 mg and Itopride 200 mg in people with Healthy, 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 2 inclusion and 11 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 9 Feb 2017. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Gastric emptying (time frame: one week). 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 9 Feb 2017.