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| Name | Class |
|---|---|
| Rawalpindi Medical College, Pakistan | OTHER |
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The goal of this study is to "To compare the efficacy and safety of Acotiamide versus Itopride in patient with post prandial distress syndrome type of functional dyspepsia"
Investigator is aiming to conduct an Open-label, comparative randomized controlled, parallel, two-arms, multi-center study.
Primary Outcomes:
• Difference in overall treatment effect between both groups by using Leuven Postprandial Distress Scale (LPDS) in 8 weeks from the baseline
Secondary Outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| assignment of participants to treatment group A (Acotiamide) | Active Comparator |
| |
| assignment of participants to treatment group B (Itopride). | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acotiamide | Drug | Both these drugs are used for the management of PDS type of FD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in overall treatment effect between both groups by using Leuven Postprandial Distress Scale in 8 weeks | Overall treatment effect will be assessed using the Leeds Postprandial Distress Scale, with change in total score from baseline before initiation of treatment end of treatment. The decreased score representing the treatment response. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between both groups in symptoms of Postprandial Distress Syndrome (PDS) (including early satiety, abdominal bloating, postprandial fullness) by using Leuven Postprandial Distress Scale | All the symptoms of PDDS will be assessed by using the Leeds Postprandial Distress Scale (LPDS), with change in total score from baseline before treatment initiation to end of treatment going downwards representing the treatment response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahaveer MR Maheshwari, MBBS | Contact | +923202521918 | mahaveer.maheshwari@getzpharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Muahmmad Umar, MBBS, FCPS, FACG, AGAF, FRCP | Rawalpindi Medical University/College | Principal Investigator |
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it will be decided after closing of enrollment
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| ID | Term |
|---|---|
| C410959 | Z 338 |
| C102254 | itopride |
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Open-label, comparative randomized, parallel, two-arms, multi-center study. A permuted block randomization technique was applied to generate an individual list of random assignment of participants to treatment group A (Acotiamide) and treatment group B (Itopride). A block represents a separate center/site of enrollment, and each center will enroll total 50 - 55 participants as per protocol. There will be total 3 recruitment centers, and each recruiting center will follow the provided list of random assignments (Annexure). An online software (https://www.sealedenvelope.com/simple-randomiser/v1/lists) was used to generate a random sequence for total 152 subjects with balanced distribution method.
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| 8 weeks |
| Difference between both groups in quality of life by using short form Nepean Dyspepsia Index scale | Quality of life will be assessed using the Nepean Dyspepsia Index, defined as the change in total score from baseline to the end of the treatment with lower scores indicating improvement | 8 weeks |
| Frequency of adverse events, serious adverse events and tolerability in both groups | Frequency of adverse events will be assessed through a patient diary maintained throughout the study, with entries reviewed at each visit | 8 weeks |