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Completed

NCT Number: NCT01076478

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

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.

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Key information

Conditions

Polyneuropathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Santo Tomas Hospital

Manila, Philippines

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Cilostazol

Drug

100 mg, 200mg tablet Cilostazol

Other names: Cilostazol, Pletaal, Pletal

Primary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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.

    Time frame: 12 weeks

  4. To determine the relationship of peripheral neuropathy with peripheral vascular disease using the WIQ and the ABI from baseline to W12.

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. To determine if there is improvement in objective parameters using NIS and NCS from baseline to W4, W8 and W12 after Cilostazol therapy.

    Time frame: 12 weeks

  3. 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.

    Time frame: 12 weeks

  4. To assess the safety of Cilostazol therapy.

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical, Inc., Philippines

Industry

Registry information

Acronym: ASCEND

Important dates

Study start
2004
Study completion
2009
First posted
Feb 26, 2010
Registry last updated
Feb 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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