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Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

K

Korea United Pharm

Status and phase

Completed
Phase 3

Conditions

Functional Dyspepsia

Treatments

Drug: UI05MSP015CT
Drug: Gasmotin

Study type

Interventional

Funder types

Industry

Identifiers

NCT03225248
KUP-MSP5-301

Details and patient eligibility

About

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.

Full 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.

Enrollment

143 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

143 participants in 2 patient groups

UI05MSP015CT
Experimental group
Description:
UI05MSP015CT and Placebo of Gasmotin
Treatment:
Drug: UI05MSP015CT
Gasmotin
Active Comparator group
Description:
Placebo of UI05MSP015CT and Gasmotin
Treatment:
Drug: Gasmotin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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