Diabetic NeuropathiesPhase 3NCT01261143
Randomized, Double-blind Study to Assess the Efficacy and Safety of α-lipoic Acid Versus BK-C-0701 in Subjects With Diabetic Neuropathy
A Phase 3 study testing BK-C-0701 in people with Diabetic Neuropathies, run by Bukwang Pharmaceutical at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the: Primary end point change of Total symptom score Secondary end point neurological test Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- BK-C-0701
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus (Type I or II), as defined by the American Diabetes Association, 1997, lasting 1 year and is well-controlled.
- Patient with symmetric sensory-motor Diabetic Neuropathy which is above stage 2
- Result of pin-prick test is 'absent' or 'reduced'
- HbA1C <10%
- Total Symptom Score ≥ 4 points
- At least 1 of the 4 symptoms of the TSS must have occurred continuously over the last 3 months.
- Patient over 19 years of age
- Female who is postmenopausal or is willing to use an effective method of contraception during the study (Effective method=IUD, spermicide with condom, abstinence) or is surgically sterile (underwent a total hysterectomy or bilateral tubal ligation).
Who cannot join
- Patient who has Proximal asymmetric neuropathy, cranial neuropathies, truncal radiculopathy, diabetic plexopathies, acute or active mononeuropathies (cranial neuropathies, post-herpes neuralgias)
- Patient who has Neuropathy from alcohol, drug (cisplatin, taxol , etcs), malignant cancer or has a medical history of nerve system disease such as Parkinson's disease/ epilepsy/ Multiple sclerosis, etcs.
- Patient who has nerve system disease which can cause sensory loss Myopathy of any cause.
- Peripheral vascular disease severe enough to cause ischemic ulcers or limb ischemia.
- Patients with diabetic proliferating retinopathy requiring immediately therapy and impending blindness.
- Patients with any active neoplastic disease except benign tumor or nonrecurrent malignant tumor for 5 years.
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- Patients with clinically significant cardiac, pulmonary, gastrointestinal, haematological, or endocrine disease that may confound interpretation of the study results or prevent the patient from completing the study.
- Patients with atrial fibrillation.
- Patients who have had organ transplants of any kind.
- Patients with significant hepatic or renal disease (AST, ALT or GGT >2 times normal, serum creatinine >1.8 mg/dL (>159 mmol/l) for males or >1.6 mg/dL (>141 mmol/l) for females).
- Patients with a recent history (within last 12 months) of drug or alcohol abuse.
- Use of any investigational drug (participation in a clinical trial) within last 1 month.
- History of severe or anaphylactic reaction to drugs, sulfur or biologic products.
- Recent (within last 3 months) ketoacidosis or hypoglycaemia, necessitating hospital admission.
- Existing foot ulcers.
- Pregnant or lactating females
- History of allergic reaction to the study medication or its excipients.
- Psychiatric, psychological, or behavioural symptoms that would interfere with the patient's ability to participate in the trial.
- Patient who is not suitable to trial by investigator judgment.
- Patient who does not write informed consent prior to start of trial and cannot comply with the trial requirements.
- Antioxidant therapy (vitamins E > 400 IU, C > 200 mg, and beta-Carotene > 30 mg) or pentoxyphylline within last 1 month before start of trial.
- Use of thioctic acid (> 50 mg), evening primrose oil or any other gamma-linolenic acid containing substance within the last 3 months.
- Use of analgesic within >5times of a half-life before administration of investigational medication.
- Use of anticonvulsants(include Pregabalin), antidepressants within 4 weeks before administration of investigational medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Randomized, Double-blind Study to Assess the Efficacy and Safety of α-lipoic Acid Versus BK-C-0701 in Subjects With Diabetic Neuropathy
The purpose of this study is to determine the:
Primary end point
- change of Total symptom score
Secondary end point
- neurological test
Read the detailed description
total symptom score shall be calculated from the data of burning, numbness, stabbing pain, paraesthesiae.
- Conditions
- Diabetic Neuropathies
- Being tested
- BK-C-0701
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BK-C-0701Drug
tablet, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| BK-C-0701, diabetic neuropathy | Experimental | Not described Receives: Drug: BK-C-0701 |
| alpha lipoic acid, diabetic neuropathy, capsule | Active comparator | Not described Receives: Drug: BK-C-0701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
TSS
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bukwang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261143
- Sponsor's protocol ID
- BK-C-0701-301
- Status last verified
- Oct 2011
- First submitted
- 10 Dec 2010
- Last updated
- 25 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized, Double-blind Study to Assess the Efficacy and Safety of α-lipoic Acid Versus BK-C-0701 in Subjects With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT01261143
- Acronym / sponsor ID
- BK-C-0701-301
- Conditions
- Diabetic Neuropathies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Apr 2012 (actual)
- First posted
- 16 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the:
Primary end point
- change of Total symptom score
Secondary end point
- neurological test
Detailed description
total symptom score shall be calculated from the data of burning, numbness, stabbing pain, paraesthesiae.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BK-C-0701, diabetic neuropathy | Experimental | Drug: BK-C-0701 |
| alpha lipoic acid, diabetic neuropathy, capsule | Active comparator | Drug: BK-C-0701 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diabetes mellitus (Type I or II), as defined by the American Diabetes Association, 1997, lasting 1 year and is well-controlled.
- Patient with symmetric sensory-motor Diabetic Neuropathy which is above stage 2
- Result of pin-prick test is 'absent' or 'reduced'
- HbA1C <10%
- Total Symptom Score ≥ 4 points
Key exclusion criteria (24 listed)
- Patient who has Proximal asymmetric neuropathy, cranial neuropathies, truncal radiculopathy, diabetic plexopathies, acute or active mononeuropathies (cranial neuropathies, post-herpes neuralgias)
- Patient who has Neuropathy from alcohol, drug (cisplatin, taxol , etcs), malignant cancer or has a medical history of nerve system disease such as Parkinson's disease/ epilepsy/ Multiple sclerosis, etcs.
- Patient who has nerve system disease which can cause sensory loss Myopathy of any cause.
- Peripheral vascular disease severe enough to cause ischemic ulcers or limb ischemia.
- Patients with diabetic proliferating retinopathy requiring immediately therapy and impending blindness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BK-C-0701tablet, 8 weeks | Drug | BK-C-0701, diabetic neuropathy, alpha lipoic acid, diabetic neuropathy, capsule |
Primary outcome
TSS
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BK-C-0701 in people with Diabetic Neuropathies, run by Bukwang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TSS (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2012.