[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site

Study’s contact

Call center

+81-3-6225-1111(M-F 9-5 JST)

Email address

dsclinicaltrial@daiichisankyo.co.jp

Condition

Diabetic Peripheral Neuropathic Pain

Treatment type

Interventional

Investigational product

Mirogabalin

Phase

Phase 3

Sponsor

Daiichi Sankyo, Inc.

ClinicalTrials.gov identifier

NCT04094662

Study number

DS5565-A-A315

Understanding clinical trials

Get answers to your questions about clinical trials.

About the study

Investigate the efficacy and safety of mirogabalin in Chinese participants with diabetic peripheral neuropathic pain in comparison to placebo.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria
  1. Type 1 or type 2 diabetes mellitus at screening
  2. Painful distal symmetric polyneuropathy, diagnosed at least 6 months prior to screening (see Procedures manual for the Diagnosis of Diabetic Peripheral Neuropathy and Neurological Examination for details)
Exclusion criteria
  1. HbA1c (National Glycohemoglobin Standardization Program) > 10.0% at screening
  2. Uncontrolled blood glucose within 1 month prior to screening, at screening or randomization
  3. Other severe pain at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP
  4. Neurologic disorders at screening or randomization, unrelated to DPN, that may confound the assessment of DPNP
  5. Major psychiatric disorders at screening or randomization
  6. Creatinine clearance (using the Cockcroft-Gault equation) < 60 mL/min at screening

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site