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

NCT01076478 | Completed Phase 4

• 1 other identifier: PLT-004-01
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polyneuropathy

Keywords

Symmetric Diabetic Polyneuropathy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (3)

Arm 1

PLACEBO COMPARATOR

2 tablets BID

Drug: Cilostazol

Arm 2

EXPERIMENTAL

100 mg Cilostazol (2 tablets BID)

Drug: Cilostazol

Arm 3

EXPERIMENTAL

200 mg Cilostazol (2 Tablets BID)

Drug: Cilostazol

Interventions

Cilostazol DRUG

100 mg, 200mg tablet Cilostazol

Also known as: Cilostazol, Pletaal, Pletal

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Presence of predominantly distal symmetrical sensory polyneuropathy of the lower limbs as assessed by NSS, NIS and NCS.

You may not qualify if:

• Current use of potentially neuropathic agents (Isoniazid, Phenytoin, Dapsone, Metronidazole, Vinca Alkaloids, etc.) within the past 1 month;
• Presence of severe metabolic disease (renal failure, hepatic failure, etc.), alcoholism and malignancy;
• Presence of hemorrhagic tendencies;
• Patients who are diagnosed to be of Type 1 Diabetes Mellitus;
• Pregnant and lactating patients, including those who plan to have pregnancy within the study period.
• Concomitant intake of agents currently used to treat neuropathic pain like gabapentin, carbamazepine/ oxcarbazepine, anti-depressants (tricyclic anti-depressants and SSRIs) and topical capsaicin.
• Concomitant intake of other anti-platelet agents, rheologic agents and anticoagulants.
• Have received Cilostazol therapy within the past three (3) months

Sponsors & Collaborators

• Otsuka Pharmaceutical, Inc., Philippines: lead

Study Sites (1)

University of Santo Tomas Hospital

Manila, Philippines

Location

MeSH Terms

Conditions

Polyneuropathies

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Raymond Rosales, MD, PhD

  University of Santo Tomas Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 24, 2010
• First Posted: February 26, 2010
• Study Start: March 1, 2004
• Study Completion: November 1, 2009
• Last Updated: February 26, 2010

Record last verified: 2010-02

Locations

PH (1)