A Unblinded Study of TAK-438 (20 mg) for Prevention of Recurrence of Gastric or Duodenal Ulcer During Long-Term Non-Steroid Anti-Inflammatory Drug (NSAID) Therapy

NCT01568385 | Completed Phase 3

• 3 other identifiers: TAK-438/OCT-303U1111-1128-5905JapicCTI-121789
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 18

Brief Summary

The purpose of this study is to study the safety and efficacy of TAK-438, once daily (QD), in participants with a history of gastric or duodenal ulcer requiring long-term NSAID therapy will be investigated.

Conditions

Gastric Ulcer; Duodenal Ulcer

Keywords

Gastric or duodenal ulcer

Outcome Measures

Primary Outcomes (1)

• Adverse Event

  24 weeks

Study Arms (1)

TAK-438 20 mg QD

EXPERIMENTAL

Drug: TAK-438

Interventions

TAK-438 DRUG

TAK-438 20 mg QD

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who, in the opinion of the principal investigator or subinvestigator, are capable of understanding the details of the study and complying with them.
• Prior to study commencement, participants who are capable of signing and dating the information/consent form.
• Participants with a chronic disease (rheumatoid arthritis, osteoarthritis, etc.) which requires continuous NSAID oral therapy for pain control during treatment period.
• Participants who meet either 1 or 2 below according to gastric or duodenal endoscopy:
• Ulcer scar (defined, in this study, as regenerative mucosa, convergence of mucosal fold, gastric wall transformation, etc) has been confirmed during endoscopy on the study drug initiation day (Visit 2).
• Ulcer (mucosal defects of 3 mm or larger with white moss) or ulcer scar has been endoscopically confirmed before the study drug initiation day (Visit 2).
• Outpatient participants (inpatients for examinations are acceptable)
• Women with child-bearing potential must agree to routinely take appropriate contraceptive measures throughout treatment period, from giving consent to the study until 4 weeks after the final dose

You may not qualify if:

• Participants who received treatment with another study drug (including approved drugs under post-marketing surveillance) within 84 days prior to commencement of screening
• Participants who have previously received TAK-438 in a clinical study or as a treatment
• Participants who are employees of institutions participating in this study and family members of such employees, participants in a dependent relationship with employees of institutions involved in conduct of the study (e.g., spouse, parent, child, sibling), and participants who are under duress in giving their consent
• Participants who have donated 400 mL or more of blood within 90 days prior to the commencement of screening
• Participants with a plan to change the type, dosage or administration of NSAID
• Participants with ulcer (mucosal defects of 3 mm or larger with white moss) or active hemorrhage confirmed during gastric or duodenal endoscopy on the study drug initiation day (Visit 2)
• Participants with small intestinal hemorrhage, large intestinal hemorrhage, or gastrointestinal hemorrhage of unknown cause
• Participants with a history of surgery or scheduled surgery influencing gastric acid secretion (resection of upper gastrointestinal tract or vagotomy etc)
• Participants with a history or complication of Zollinger-Ellison syndrome, or other gastric acid hypersecretion disorders
• Participants with a history or complication of aspirin asthma
• Participants who have a history of hypersensitivity or allergy to TAK-438 (including its excipients) or NSAIDs
• Participants with current use of illicit drug or a history of drug abuse. and/or alcohol dependence within one year prior to the commencement of screening
• Participants who require treatment with prohibited concomitant drugs or therapies (see 7.3)
• Female participants who are pregnant or lactating; those who plan to become pregnant or donate ova during treatment period, from giving consent until 4 weeks after final dose
• Participants with serious central nervous system disorders, cardiovascular disease, pulmonary disease, hepatic disease, renal disease, metabolic disease, gastrointestinal disorders, urinary disorders, endocrine disease, or blood dyscrasia

Sponsors & Collaborators

• Takeda: lead

Study Sites (18)

Unknown Facility

Funabashi-shi, Chiba, Japan

Location

Unknown Facility

Noda, Chiba, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Annaka-shi, Gunma, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, Japan

Location

Unknown Facility

Hakodate-shi, Hokkaido, Japan

Location

Unknown Facility

Kitahiroshima-shi, Hokkaido, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Yubari-gun, Hokkaido, Japan

Location

Unknown Facility

Kanazawa, Ishikawa-ken, Japan

Location

Unknown Facility

Sanuki-shi, Kagawa-ken, Japan

Location

Unknown Facility

Yashiro-shi, Kumamoto, Japan

Location

Unknown Facility

Nagasaki, Nagasaki, Japan

Location

Unknown Facility

Sasebo-shi, Nagasaki, Japan

Location

Unknown Facility

Fuchu-shi, Tokyo, Japan

Location

Unknown Facility

Katsushika-ku, Tokyo, Japan

Location

Unknown Facility

Meguro-ku, Tokyo, Japan

Location

Unknown Facility

Nakano-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Stomach Ulcer; Duodenal Ulcer

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 10, 2014

Record last verified: 2014-02

Locations

JP (18)