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Asian Study on Cilostazol Effectivity in Neuropathies of Diabetes Mellitus Type 2-A Pilot Study in the Philippines (ASCEND)

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ClinicalTrials.gov Identifier: NCT01076478
Recruitment Status : Completed
First Posted : February 26, 2010
Last Update Posted : February 26, 2010
Sponsor:
Information provided by:
Otsuka Pharmaceutical, Inc., Philippines

Tracking Information
First Submitted Date  ICMJE February 24, 2010
First Posted Date  ICMJE February 26, 2010
Last Update Posted Date February 26, 2010
Study Start Date  ICMJE March 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
  • Subjective neuropathy assessment by NSS (Neuropathy Symptom Scores)from Baseline (BS) to week 12 (W12) after Cilostazol therapy of the three (3) arms of the study. [ Time Frame: 12 weeks ]
  • Objective neuropathy assessment by NIS (Neuropathy Impairment Scores)from Baseline (BS) to week 12 (W12) after Cilostazol therapy of the three (3) arms of the study. [ Time Frame: 12 weeks ]
  • Electrophysiologic assessment by NCS (Nerve Conduction Studies) from Baseline (BS) to week 12 (W12) after Cilostazol therapy of the three (3) arms of the study. [ Time Frame: 12 weeks ]
  • To determine the relationship of peripheral neuropathy with peripheral vascular disease using the WIQ and the ABI from baseline to W12. [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
  • To determine if there is improvement in subjective parameters of neuropathy as assessed by NSS and NSC (Neuropathy Symptoms and Change Questionnaire) from baseline to week 4 (W4), week 8 (W8) and week 12 (W12) after Cilostazol therapy. [ Time Frame: 12 weeks ]
  • To determine if there is improvement in objective parameters using NIS and NCS from baseline to W4, W8 and W12 after Cilostazol therapy. [ Time Frame: 12 weeks ]
  • To compare the effectivity of low dose (100mg) and high dose (200mg) Cilostazol based on subjective (NSS, NSC) and objective parameters (NIS, NCS) from baseline, to W4, W8 and W12. [ Time Frame: 12 weeks ]
  • To assess the safety of Cilostazol therapy. [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Asian Study on Cilostazol Effectivity in Neuropathies of Diabetes Mellitus Type 2-A Pilot Study in the Philippines
Official Title  ICMJE Not Provided
Brief Summary To describe if there are differences in the subjective, objective and electrophysiologic parameters of diabetic polyneuropathies at baseline, four (4) weeks, eight (8) weeks, and twelve (12) weeks after Cilostazol therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Polyneuropathy
Intervention  ICMJE Drug: Cilostazol
100 mg, 200mg tablet Cilostazol
Other Name: Cilostazol, Pletaal, Pletal
Study Arms  ICMJE
  • Placebo Comparator: Arm 1
    2 tablets BID
    Intervention: Drug: Cilostazol
  • Experimental: Arm 2
    100 mg Cilostazol (2 tablets BID)
    Intervention: Drug: Cilostazol
  • Experimental: Arm 3
    200 mg Cilostazol (2 Tablets BID)
    Intervention: Drug: Cilostazol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2010)
47
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Signed written informed consent 2. Male and Female ages 18 to 70 years old. To be able to eliminate Type I Diabetes Mellitus among the younger subjects, we will only recruit patients who are stable on oral hypoglycemic agent. 3. Established diagnosis of diabetes mellitus type 2 (National Diabetes Data Group) who are currently on good control of the diabetic state.

4. Presence of predominantly distal symmetrical sensory polyneuropathy of the lower limbs as assessed by NSS, NIS and NCS.

Exclusion Criteria:

  1. Current use of potentially neuropathic agents (Isoniazid, Phenytoin, Dapsone, Metronidazole, Vinca Alkaloids, etc.) within the past 1 month;
  2. Presence of severe metabolic disease (renal failure, hepatic failure, etc.), alcoholism and malignancy;
  3. Presence of hemorrhagic tendencies;
  4. Patients who are diagnosed to be of Type 1 Diabetes Mellitus;
  5. Pregnant and lactating patients, including those who plan to have pregnancy within the study period.
  6. Concomitant intake of agents currently used to treat neuropathic pain like gabapentin, carbamazepine/ oxcarbazepine, anti-depressants (tricyclic anti-depressants and SSRIs) and topical capsaicin.
  7. Concomitant intake of other anti-platelet agents, rheologic agents and anticoagulants.
  8. Have received Cilostazol therapy within the past three (3) months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Philippines
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01076478
Other Study ID Numbers  ICMJE PLT-004-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Evelio Valdes/CRA, Otsuka Pharmaceutical, Inc., Philippines
Study Sponsor  ICMJE Otsuka Pharmaceutical, Inc., Philippines
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raymond Rosales, MD, PhD University of Santo Tomas Hospital
PRS Account Otsuka Pharmaceutical, Inc., Philippines
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP