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A Study to Evaluate the Efficacy and Safety of TAK-906 in Adult Participants With Symptomatic Idiopathic or Diabetic Gastroparesis

NCT03544229 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2022-11-16

Study results available
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Summary

The purpose of this study is to assess the efficacy and safety of treatment with 2 dose levels of TAK-906 in adult participants with gastroparesis compared with placebo during 12 weeks of treatment.

Conditions

  • Diabetic Gastroparesis
  • Idiopathic Gastroparesis

Interventions

DRUG

TAK-906 Maleate

TAK-906 maleate capsules.

DRUG

Placebo

TAK-906 maleate placebo-matching capsules.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-14
Primary Completion
2021-06-14
Completion
2021-07-15
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Japan
  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03544229 on ClinicalTrials.gov