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

NCT ID: NCT01076478

Last Updated: 2010-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2009-11-30

Brief Summary

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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

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Conditions

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Polyneuropathy

Keywords

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Symmetric Diabetic Polyneuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Arm 1

2 tablets BID

Group Type PLACEBO_COMPARATOR

Cilostazol

Intervention Type DRUG

100 mg, 200mg tablet Cilostazol

Arm 2

100 mg Cilostazol (2 tablets BID)

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

100 mg, 200mg tablet Cilostazol

Arm 3

200 mg Cilostazol (2 Tablets BID)

Group Type EXPERIMENTAL

Cilostazol

Intervention Type DRUG

100 mg, 200mg tablet Cilostazol

Interventions

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Cilostazol

100 mg, 200mg tablet Cilostazol

Intervention Type DRUG

Other Intervention Names

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Cilostazol, Pletaal, Pletal

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical, Inc., Philippines

INDUSTRY

Sponsor Role lead

Responsible Party

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Otsuka Pharmaceutical, Inc., Philippines

Principal Investigators

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Raymond Rosales, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Santo Tomas Hospital

Locations

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University of Santo Tomas Hospital

Manila, , Philippines

Site Status

Countries

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Philippines

Other Identifiers

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PLT-004-01

Identifier Type: -

Identifier Source: org_study_id