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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03225248
Other study ID # KUP-MSP5-301
Secondary ID
Status Completed
Phase Phase 3
First received July 12, 2017
Last updated July 20, 2017
Start date November 5, 2014
Est. completion date October 12, 2015

Study information

Verified date July 2017
Source Korea United Pharm. Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a multi-center, randomized, active-controlled, double-blind, non-inferiority, phase III clinical trial evaluating efficacy and safety of once-daily mosapride (UI05MSP015CT) in patients with functional dyspepsia.


Description:

Patients with functional dyspepsia were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once daily before breakfast, study group) or mosapride (5 mg three times a day before each meal, control group) and corresponding placebo t.i.d. or q.d. for 4 weeks.


Recruitment information / eligibility

Status Completed
Enrollment 143
Est. completion date October 12, 2015
Est. primary completion date September 5, 2015
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

1. Age >19 years

2. Diagnosis of functional dyspepsia meeting Rome III criteria

3. At least three moderate or severe symptoms included in the Symptom Score

4. No structural lesions of upper gastrointestinal tract

Exclusion Criteria:

1. History of dyspepsia unrelated to functional dyspepsia or diseases

2. History of gastrointestinal surgery

3. History of malignancy in the previous 5 years

4. Psychiatric disorders including major depressive disorder and anxiety

5. Liver cirrhosis or abnormal liver laboratory findings

6. Advanced chronic kidney disease

7. Uncontrolled hypertension

8. Uncontrolled diabetes

9. Pregnancy and lactation

10. Recent history of taking medication affecting the gastrointestinal system

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
UI05MSP015CT
UI05MSP015CT and Placebo of Gasmotin
Gasmotin
Placebo of UI05MSP015CT and Gasmotin

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Korea United Pharm. Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Change of symptom score of functional dyspepsia Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire. 4weeks
Secondary Change of symptom score of functional dyspepsia Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire. 2weeks
Secondary General symptom improvement Selecting: 'loss of symptom', 'apparent improvement', 'moderate improvement', 'no change', and 'deterioration'. 2weeks, 4weeks
Secondary NDI-K questionnaire 25 questions on five quality of life areas 4weeks
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