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

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.

Study Overview

• Status: Completed
• Conditions: Polyneuropathy
• Intervention / Treatment: Drug: Cilostazol

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 4

Contacts and Locations

Study Locations

• Philippines
  • Manila, Philippines
    • University of Santo Tomas Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Arm 1; 2 tablets BID	Drug: Cilostazol; 100 mg, 200mg tablet Cilostazol; Other Names: Cilostazol, Pletaal, Pletal
Experimental: Arm 2; 100 mg Cilostazol (2 tablets BID)	Drug: Cilostazol; 100 mg, 200mg tablet Cilostazol; Other Names: Cilostazol, Pletaal, Pletal
Experimental: Arm 3; 200 mg Cilostazol (2 Tablets BID)	Drug: Cilostazol; 100 mg, 200mg tablet Cilostazol; Other Names: Cilostazol, Pletaal, Pletal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical, Inc., Philippines
• Investigators: Principal Investigator: Raymond Rosales, MD, PhD, University of Santo Tomas Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: February 24, 2010
• First Submitted That Met QC Criteria: February 25, 2010
• First Posted (Estimate): February 26, 2010

Study Record Updates

• Last Update Posted (Estimate): February 26, 2010
• Last Update Submitted That Met QC Criteria: February 25, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Symmetric Diabetic Polyneuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Polyneuropathies; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Neuroprotective Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Cilostazol
• Other Study ID Numbers: PLT-004-01