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

Polyneuropathy Clinical Trial

— ASCEND  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076478
• Other study ID #: PLT-004-01
• Status: Completed
• Phase: Phase 4
• First received: February 24, 2010
• Last updated: February 25, 2010
• Start date: March 2004
• Est. completion date: November 2009

Study information

• Verified date: February 2010
• Source: Otsuka Pharmaceutical, Inc., Philippines
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Philippine Council for Health Research and Development
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polyneuropathies
• Polyneuropathy

Intervention

Drug:
• Cilostazol
100 mg, 200mg tablet Cilostazol

Locations

Country	Name	City	State
Philippines	University of Santo Tomas Hospital	Manila

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical, Inc., Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	No
Primary	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	No
Primary	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	No
Primary	To determine the relationship of peripheral neuropathy with peripheral vascular disease using the WIQ and the ABI from baseline to W12.		12 weeks	No
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	No
Secondary	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	No
Secondary	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	No
Secondary	To assess the safety of Cilostazol therapy.		12 weeks	No