search
Back to results

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

Primary Purpose

Polyneuropathy

Status
Completed
Phase
Phase 4
Locations
Philippines
Study Type
Interventional
Intervention
Cilostazol
Sponsored by
Otsuka Pharmaceutical, Inc., Philippines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polyneuropathy focused on measuring Symmetric Diabetic Polyneuropathy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

Sites / Locations

  • University of Santo Tomas Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

2 tablets BID

100 mg Cilostazol (2 tablets BID)

200 mg Cilostazol (2 Tablets BID)

Outcomes

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

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

Full Information

First Posted
February 24, 2010
Last Updated
February 25, 2010
Sponsor
Otsuka Pharmaceutical, Inc., Philippines
search

1. Study Identification

Unique Protocol Identification Number
NCT01076478
Brief Title
Asian Study on Cilostazol Effectivity in Neuropathies of Diabetes Mellitus Type 2-A Pilot Study in the Philippines
Acronym
ASCEND
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Otsuka Pharmaceutical, Inc., Philippines

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polyneuropathy
Keywords
Symmetric Diabetic Polyneuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Placebo Comparator
Arm Description
2 tablets BID
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
100 mg Cilostazol (2 tablets BID)
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
200 mg Cilostazol (2 Tablets BID)
Intervention Type
Drug
Intervention Name(s)
Cilostazol
Other Intervention Name(s)
Cilostazol, Pletaal, Pletal
Intervention Description
100 mg, 200mg tablet Cilostazol
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
To assess the safety of Cilostazol therapy.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Rosales, MD, PhD
Organizational Affiliation
University of Santo Tomas Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Santo Tomas Hospital
City
Manila
Country
Philippines

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs