Efficacy and Safety of Dexlansoprazole on Heartburn Relief in Chinese Patients

Last updated: July 3, 2019
Sponsor: Takeda
Overall Status: Completed

Phase

3

Condition

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Treatment

N/A

Clinical Study ID

NCT02873689
TAK-390MR_302
U1111-1171-1002
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to determine the efficacy and safety of dexlansoprazole compared to placebo in relief of daytime and nighttime heartburn over 4 weeks in Chinese participants with symptomatic non-erosive Gastroesophageal Reflux Disease (GERD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants identifying their main symptom as a burning feeling in the mid-epigastricarea and/or chest area (that is, heartburn).

  2. Must have a history of symptomatic GERD for 6 months or longer prior to Screening withGERD symptoms that were responsive to acid-suppressive therapy.

  3. Must have episodes of heartburn for 4 or more days during the 7 days prior to Day -1as recorded in the eDiary.

Exclusion

Exclusion Criteria:

  1. Has a history of cancer (except basal cell carcinoma of the skin), that has not beenin remission for at least 5 years prior to Screening.

  2. Has a known history of Barrett's esophagus with dysplastic changes or any changessuspicious Barrett's seen during screening endoscopy.

  3. Participant developed acute upper gastrointestinal bleeding, gastric ulcer (a mucosaldefect with white coating) or duodenal ulcer (a mucosal defect with white coating),within 30 days before the start of the Screening Visit (with the possible inclusion ofthose with gastric or duodenal erosion). The participant requires chronic use (greaterthan [>] 12 doses per month) of nonsteroidal anti-inflammatory drugs (NSAIDs)including cyclooxygenase-2 (COX-2) NSAIDs within 30 days prior to the Screening Periodand throughout the study.

  4. Has comorbidities that could affect the esophagus (eosinophilic esophagitis,esophageal varices, scleroderma, viral or fungal infection, esophageal strictures); ahistory of radiotherapy or cryotherapy of the esophagus; and a history of corrosive orphysiochemical injury (with the possible inclusion in the study of those withSchatzki's ring).

  5. Has a history of surgical procedures that may affect the esophagus (example,fundoplication and mechanical dilatation for esophageal strictures) or a history ofgastric or duodenal surgery other than endoscopic removal of benign polyps.

  6. Has erosive esophagitis (EE) as shown by endoscopy, during the Screening Period.

  7. Is known to have acquired immunodeficiency syndrome (AIDS) or hepatitis, includinghepatitis virus carriers: (that is, hepatitis B surface antigen HBs-antigen (HBsAg)positive or hepatitis C virus (HCV)-antibody positive).

  8. Has current or historical evidence of Zollinger-Ellison syndrome or a history ofgastric acid hypersecretion.

  9. Is scheduled for surgery that requires hospitalization or requires surgical treatmentduring his/her participation in the study.

  10. Has donated or lost >300 milliliter (mL) blood volume, undergone plasmapheresis, orhas had a transfusion of any blood product within 90 days prior to the first dose ofstudy drug.

  11. Has a history of alcohol abuse (defined as any illicit drug use), or drug addiction inthe 12 months prior to Screening.

  12. Participant with positive serology result of Helicobacter pylori (H. pylori) thatneeds eradication therapy during the study participation period as anticipated by theinvestigator.

Study Design

Total Participants: 217
Study Start date:
December 27, 2016
Estimated Completion Date:
April 19, 2018

Study Description

The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being tested to treat heartburn in people who have non-erosive gastroesophageal reflux disease (GERD). This study will look at heartburn relief in people who take dexlansoprazole.

The study will enroll approximately 200 participants. Participants will be randomly assigned to one of the two treatment groups with 1:1 ratio —which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

  • Dexlansoprazole 30 mg

  • Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has no active ingredient.

All participants will be asked to take one capsule at the same time each day throughout the study, and will be asked to record any time they have heartburn symptoms in a diary.

This multi-center trial will be conducted in China. The overall time to participate in this study is up to 7 weeks. Participants will make 4 visits to the clinic, and will be contacted by telephone 5 to 10 days after the last dose of study drug for a follow-up assessment.

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, Beijing 100032
    China

    Site Not Available

  • Chongqing Three Gorges Central Hospital

    Chong Qing, Chong Qing 404100
    China

    Site Not Available

  • Zhongshan Hospital Xiamen University

    Xia Men, Fu Jian 361004
    China

    Site Not Available

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nan Ning, Guang XI 530022
    China

    Site Not Available

  • Affilicated Hospital of Guilin Medical University

    Hai Kou, Gui Lin 570100
    China

    Site Not Available

  • Hebei General Hospital

    Shijiazhuang, Hebei 050051
    China

    Site Not Available

  • Taihe Hospital

    Shi Yan, Hu Bei 442000
    China

    Site Not Available

  • Central Hospital of Wuhan

    Wuhan, Hu Bei 430000
    China

    Site Not Available

  • Puai Hospital Of Wuhan City

    Wuhan, Hu Bei 430000
    China

    Site Not Available

  • The Third Hospital of Changsha

    Chang Sha, Hu Nan 410015
    China

    Site Not Available

  • empty

    Shiyan, Hubei
    China

    Site Not Available

  • Zhongda Hospital Southeast

    Nan Jing, Jiang Su 210009
    China

    Site Not Available

  • Affiliated Hospital of Jiangsu University

    Wu XI, Jiang Su 212001
    China

    Site Not Available

  • Wuxi people's hospital

    Wu XI, Jiang Su 214023
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130000
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning 110004
    China

    Site Not Available

  • Binzhou Medical University Hospital

    Binzhou, Shandong 256603
    China

    Site Not Available

  • Jinan Central Hospital

    Jinan, Shandong 250013
    China

    Site Not Available

  • Liaocheng Hospital

    Liaocheng, Shandong 252000
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong 266003
    China

    Site Not Available

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 20001
    China

    Site Not Available

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi 030001
    China

    Site Not Available

  • The Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi 030001
    China

    Site Not Available

  • West China Hospital,Sichuan University

    Cheng Du, Si Chuang 610041
    China

    Site Not Available

  • Tianjin People's Hospital

    Tianjin, Tianjin 300121
    China

    Site Not Available

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