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

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical, Inc., Philippines
ClinicalTrials.gov Identifier:
NCT01076478
First received: February 24, 2010
Last updated: February 25, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Polyneuropathy
Drug: Cilostazol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical, Inc., Philippines:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess the safety of Cilostazol therapy. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 47
Study Start Date: March 2004
Study Completion Date: November 2009
Arms Assigned Interventions
Placebo Comparator: Arm 1
2 tablets BID
Drug: Cilostazol
100 mg, 200mg tablet Cilostazol
Other Name: Cilostazol, Pletaal, Pletal
Experimental: Arm 2
100 mg Cilostazol (2 tablets BID)
Drug: Cilostazol
100 mg, 200mg tablet Cilostazol
Other Name: Cilostazol, Pletaal, Pletal
Experimental: Arm 3
200 mg Cilostazol (2 Tablets BID)
Drug: Cilostazol
100 mg, 200mg tablet Cilostazol
Other Name: Cilostazol, Pletaal, Pletal

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076478

Locations
Philippines
University of Santo Tomas Hospital
Manila, Philippines
Sponsors and Collaborators
Otsuka Pharmaceutical, Inc., Philippines
Investigators
Principal Investigator: Raymond Rosales, MD, PhD University of Santo Tomas Hospital
  More Information

No publications provided

Responsible Party: Evelio Valdes/CRA, Otsuka Pharmaceutical, Inc., Philippines
ClinicalTrials.gov Identifier: NCT01076478     History of Changes
Other Study ID Numbers: PLT-004-01
Study First Received: February 24, 2010
Last Updated: February 25, 2010
Health Authority: Philippines: Philippine Council for Health Research and Development

Keywords provided by Otsuka Pharmaceutical, Inc., Philippines:
Symmetric Diabetic Polyneuropathy

Additional relevant MeSH terms:
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cilostazol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 02, 2014