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Trial record 12 of 39 for:    Recruiting, Not yet recruiting, Available Studies | "Dyspepsia"

Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia (PART 2)

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ClinicalTrials.gov Identifier: NCT03184402
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

Brief Summary:
The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of Functional Dyspepsia.

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Drug: DWJ1252 Drug: Gasmotin Drug: Placebo of Gasmotin Drug: Placebo of DWJ1252 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study (PART 2)
Actual Study Start Date : April 18, 2017
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Indigestion

Arm Intervention/treatment
Experimental: DWJ1252 Drug: DWJ1252
tablet

Drug: Placebo of Gasmotin
tablet

Active Comparator: Gasmotin Drug: Gasmotin
tablet

Drug: Placebo of DWJ1252
tablet




Primary Outcome Measures :
  1. The change from baseline in GIS (Gastrointestinal Symptom Score) [ Time Frame: At 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female of at least 19 years old
  • Patient with functional dyspepsia met the ROME III criteria

Exclusion Criteria:

  • Patients with previous gastrointestinal surgery
  • Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation
  • Patients with history of gastrointestinal cancer

Information from the National Library of Medicine

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): NCT03184402


Contacts
Contact: Daewoong Clinical 025508800 31101@daewoong.co.kr

Locations
Korea, Republic of
Smg-Snu Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Daewoong Clinical         
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
Investigators
Study Chair: SMG-SNU BORAMAE MEDICAL CENTER SMG-SNU Boramae Medical Center

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT03184402     History of Changes
Other Study ID Numbers: DW_DWJ1252003
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases