| Trial ID: | L6569 |
| Source ID: | NCT01076478
|
| Associated Drug: |
Cilostazol
|
| Title: |
Asian Study on Cilostazol Effectivity in Neuropathies of Diabetes Mellitus Type 2-A Pilot Study in the Philippines
|
| Acronym: |
ASCEND
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Polyneuropathy
|
| Interventions: |
DRUG: Cilostazol
|
| Outcome Measures: |
Primary: 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., 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., 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., 12 weeks|To determine the relationship of peripheral neuropathy with peripheral vascular disease using the WIQ and the ABI from baseline to W12., 12 weeks | Secondary: 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., 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., 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., 12 weeks|To assess the safety of Cilostazol therapy., 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: Otsuka Pharmaceutical, Inc., Philippines
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
47
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2004-03
|
| Completion Date: |
2009-11
|
| Results First Posted: |
|
| Last Update Posted: |
2010-02-26
|
| Locations: |
University of Santo Tomas Hospital, Manila, Philippines
|
| URL: |
https://clinicaltrials.gov/show/NCT01076478
|
