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

Otsuka

Status and phase: Completed; Phase 4

Conditions: Polyneuropathy

Treatments: Drug: Cilostazol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01076478

PLT-004-01

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

2. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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47 participants in 3 patient groups, including a placebo group

Arm 1

Placebo Comparator group

Description:

2 tablets BID

Treatment:

Drug: Cilostazol

Arm 2

Experimental group

Description:

100 mg Cilostazol (2 tablets BID)

Treatment:

Drug: Cilostazol

Arm 3

Experimental group

Description:

200 mg Cilostazol (2 Tablets BID)

Treatment:

Drug: Cilostazol