Effect of Itopride, on Symptoms of Functional Dyspepsia, Such as Indigestion, Bloating, Inability to Finish a Meal
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ClinicalTrials.gov Identifier: NCT00112190 |
Recruitment Status
:
Completed
First Posted
: June 1, 2005
Last Update Posted
: February 8, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dyspepsia | Drug: Itopride Hydrochloride Drug: itopride | Phase 3 |
The study lasts approximately 10 weeks. Patients may either receive the real itopride, or a sugar pill called placebo. They have equal chances of receiving either treatment. After having completed this study, patients may be eligible to continue treatment for a longer period. At that point, all patients receive itopride.
Patients need to come to the clinic for evaluations 4 times during the trial. Various evaluations are done at these visits, such as a physical exam, lab tests, evaluation of the heart condition, and questionnaires need to be completed by the patient to see if the drug helps them in relieving their symptoms.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 645 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Multicentre, Randomized, Double-Blind Placebo-Controlled Study of the Efficacy and Safety of Itopride HCl in Patients Suffering From Functional Dyspepsia |
Study Start Date : | July 2004 |
Actual Primary Completion Date : | March 2005 |
Actual Study Completion Date : | March 2006 |

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Drug: Itopride Hydrochloride
- Symptom relief
- Impact of symptom relief on quality of life
- Safety

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Patients suffering from functional dyspepsia according to Rome II criteria
- 18-65 years old
- Absence of, or infrequent heartburn (one episode per week or less)
- Helicobacter pylori (H. pylori) negative
- Normal upper endoscopy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112190
Canada, Quebec | |
AXCAN Pharma Inc. | |
Mont St-Hilaire, Quebec, Canada, J3H 6C4 |
Principal Investigator: | Nicholas Talley, MD | Mayo Clinic, Rochester, Minn |
Responsible Party: | Dr. N. Talley, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00112190 History of Changes |
Other Study ID Numbers: |
ITOFD04-01 |
First Posted: | June 1, 2005 Key Record Dates |
Last Update Posted: | February 8, 2017 |
Last Verified: | February 2017 |
Keywords provided by Forest Laboratories:
Functional dyspepsia Abdominal Symptom relief Fullness Bloating Indigestion |
Additional relevant MeSH terms:
Dyspepsia Signs and Symptoms, Digestive Signs and Symptoms |