Safety Study of DA-9801 to Treat Diabetic Neuropathy

This study is not yet open for participant recruitment.
Verified March 2013 by Dong-A ST Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01822925
First received: March 21, 2013
Last updated: April 3, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to determine whether DA-9801 is effective in the treatment of pain associated with diabetic neuropathy.


Condition Intervention Phase
Diabetic Neuropathy
Drug: DA-9801 300mg
Drug: DA-9801 600mg
Drug: DA-9801 900mg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Double-Blind, Parallel Group, Dose-Ranging, Placebo-Controlled Study to Assess the Safety And Effectiveness Of DA-9801 in the Treatment of Subjects With Diabetic Neuropathy

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • The reduction of average pain score compared to baseline as assessed by the Likert numerical rating scale (NRS) [ Time Frame: Assessed at Screening and then at each week for 12 weeks during the treatment period (Treatment Visit 1 through Treatment Visit 12) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in average weekly pain score during 24 hours between dose groups as assessed by daily diary [ Time Frame: Assessed weekly for 12 weeks during the treatment period (Treatment Visit 1 through Treatment Visit 12) ] [ Designated as safety issue: No ]
  • Difference in average weekly most severe pain between dose groups as assessed by daily diary [ Time Frame: Assessed weekly for 12 weeks during the treatment period (Treatment Visit 1 through Treatment Visit 12) ] [ Designated as safety issue: No ]
  • Difference in average weekly overnight pain score between dose groups as assessed by daily diary [ Time Frame: Assessed weekly for 12 weeks during the treatment period (Treatment Visit 1 through Treatment Visit 12) ] [ Designated as safety issue: No ]
  • Proportion of responders in Patient Global Impression of Improvement (PGI-I) [ Time Frame: Assessed weekly for 12 weeks during the treatment period (Treatment Visit 1 through Treatment Visit 12), and at the final visit at week 14 (2 weeks after the final treatment visit) ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impression (CGI) over the course of the study [ Time Frame: Assessed weekly for 12 weeks during the treatment period (Treatment Visit 1 through Treatment Visit 12), and at the final visit at week 14 (2 weeks after the final treatment visit) ] [ Designated as safety issue: No ]
  • Average weekly rescue medication use [ Time Frame: Assessed weekly for 12 weeks during the treatment period (Treatment Visit 1 through Treatment Visit 12) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Incidence of Adverse Events (AEs) [ Time Frame: Assessed weekly for 12 weeks during the treatment period (Treatment Visit 1 through Treatment Visit 12), and at the final visit at week 14 (2 weeks after the final treatment visit) ] [ Designated as safety issue: Yes ]
  • Incidence of withdrawals due to AEs [ Time Frame: Assessed weekly for 12 weeks during the treatment period (Treatment Visit 1 through Treatment Visit 12), and at the final visit at week 14 (2 weeks after the final treatment visit) ] [ Designated as safety issue: Yes ]
  • Changes/shifts in laboratory values [ Time Frame: Plasma samples will be taken for analysis at Screening, Treatment Visit 5 and then again at the final visit at week 14 (2 weeks after the final treatment visit) ] [ Designated as safety issue: Yes ]
  • Changes in vital signs [ Time Frame: Vitals signs will be assesed at Screening, at each week for 12 weeks during the treatment period (Treatment Visit 1 through Treatment Visit 12) and at the final visit at week 14 (2 weeks after the final treatment visit) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 128
Study Start Date: August 2013
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DA-9801 300mg
DA-9801 will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks.
Drug: DA-9801 300mg
300 mg of DA-9801 tablet to be taken 3 times daily for 12 weeks.
Experimental: DA-9801 600mg
DA-9801 will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks.
Drug: DA-9801 600mg
600 mg of DA-9801 tablet to be taken 3 times daily for 12 weeks.
Experimental: DA-9801 900mg
DA-9801 will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this medication for 12 weeks.
Drug: DA-9801 900mg
900 mg of DA-9801 tablet to be taken 3 times daily for 12 weeks.
Placebo Comparator: Placebo
Placebo (same formulation as DA-9801 but without the active ingredients) will be administered in tablet form, 3 times daily to subjects randomized to this arm of the study. Subjects will be expected to take this tablet for 12 weeks.
Drug: Placebo
Placebo tablet to be taken 3 times daily for 12 weeks. The placebo is the same formulation as DA-9801 except that it does not contain the active pharmaceutical ingredient.

Detailed Description:

This is a double-blind, randomized, parallel group, dose ranging, placebo-controlled study where eligible subjects (age 18 to 75 years) will have an average pain score ≥ 4 on an 11-point Likert numerical rating scale (NRS) for at least four days each week prior to randomization as assessed by daily pain diaries. Eligible subjects will be randomized to a 1:1:1:1 ratio to receive 300mg, 600mg, 900mg of DA-9801, or placebo three times a day for 12 weeks. During and at the end of the 12-week treatment period subjects will be evaluated for safety and efficacy parameters. A follow-up visit for safety will occur four weeks after the last treatment visit (TV).

The Screening Phase (two weeks) is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study and consists of a series of screening assessments designed to determine eligibility. Eligible subjects will undergo a two-week washout period for medications and therapies administered for pain management.

At or up to 21 days before the Screening Visit, written informed consent from (ICF) the subject will be obtained by the Investigator or a suitably qualified designee before the performance of any protocol-specific procedure.

At the Screening Visit, the subject will be issued a daily diary in order to record daily pain level during the screening phase.

The Treatment Phase (TV0 to TV12) begins with a series of assessments designed to confirm the subjects' continued eligibility. The site will collect the daily diary and the subject's pain score will be determined. Only subjects whose average pain score is ≥ 4 for at least four days each week will be randomized to any of the four treatment groups.

DA-9801 administration schedule is three times per day, starting from TV0 to TV12.

During this study phase subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include the subject's global impression of pain and CGI of improvement. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit.

The Follow-up Visit (two weeks after last TV) The Follow-up Visit is designed to assess safety and will occur 14 days after the last TV. If the subject is withdrawn from the study prior to TV12, the subject should be exited from the study AFTER completing the specified assessments for that visit.

Total study duration is a maximum of 16 weeks which includes the 2-week washout period and final visit 14 days after the last TV.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be 18 to 75 years of age
  • Diagnosed with Type I or Type II diabetes
  • HbA1c ≤ 12% at the time of screening
  • Has diabetic neuropathic pain (numbness, soreness, shooting or poking pain) in the legs for more than three months prior to screening and with no adequate relief from other treatments
  • Has an average pain score of ≥ 4 for 24 hours at least four days out of the week prior to randomization as assessed by the 11-point Likert NRS.
  • If female of childbearing potential, subject must have a negative serum pregnancy test at screening
  • Understands and is willing to participate in the clinical study and can comply with study procedures and visits.
  • Normal cognitive and communicative ability as judged by clinical assessment and ability to complete self-reported questionnaires
  • Subject is willing and able to give informed consent

Exclusion Criteria:

  • Evidence of another type of neuropathic pain caused by a condition other than diabetes
  • Pain from another source as severe or greater than the pain under study
  • BMI (Body Mass Index) > 37 kg/m2
  • Clinical signs of infection related to sores of any type on the legs
  • Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening; or subject or physician anticipates use of any of these therapies by the subject during the course of the study
  • Previous participation in the Treatment Phase of this Protocol
  • History of drug or alcohol abuse
  • Malignant disease not in remission for five years or more that has been medically or surgically treated without evidence of metastases
  • Presence of one or more medical conditions, as determined by medical history, which seriously compromises the subject's ability to complete the study, including history of poor adherence with medical treatment, renal, hepatic, hematologic, active auto-immune or immune diseases that, in the opinion of the Investigator, would make the subject an inappropriate candidate for this study: a) One or more abnormal blood biochemistry analyte result that is ≥ 3 times that of the upper limit of the normal range
  • Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history known to be infected with Human Immunodeficiency Virus (HIV)
  • New York Heart Association (NYHA) Class III and IV congestive heart failure (CHF), as defined by the following criteria: a)Class III: Symptoms with moderate exertion b)Class IV: Symptoms at rest
  • Pregnant or breast feeding
  • Subjects with a diagnosis of psychiatric disorders such as major depressive disorder, bipolar disorder, obsessive compulsive disorder, generalized anxiety, dysthymia or suicidality/suicide ideation
  • Administration of local anesthetic shot or systemic steroids within two months of screening
  • Subjects not willing to undergo a two-week washout period for pharmacologic and non-pharmacologic pain management techniques
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01822925

Contacts
Contact: Anand Balasubramanian 301-956-2531 anandb@amarexcro.com

Locations
United States, Missouri
Patterson Medical Clinic Not yet recruiting
Florissant, Missouri, United States, 63031
Contact: Donna Milos, RN    314-831-5999 ext 3010    pcresearch_milos@yahoo.com   
Principal Investigator: Mel Lucas, D.O.         
Sponsors and Collaborators
Dong-A ST Co., Ltd.
  More Information

No publications provided

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT01822925     History of Changes
Other Study ID Numbers: DA9801-DN-001
Study First Received: March 21, 2013
Last Updated: April 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dong-A ST Co., Ltd.:
Diabetes
Pain
Neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on April 17, 2014