NeuropathyPhase 4NCT02074267
Clinical Study for Assessment of the Efficacy of Gabapentin (Carbatin and Neurontin) in Patients With Neuropathy Pain
A Phase 4 study testing Carbatin and Neurontin in people with Neuropathy and Pain, run by Nang Kuang Pharmaceutical Co., Ltd. at 1 site in Taiwan.
Trial summary
The purpose of this study is to assess the efficacy of Gabapentin (Carbatin \& Neurontin) in patients with neuropathy pain. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neuropathy, Pain
- What is being tested?
- Carbatin and Neurontin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2009to Sep 2011
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have been diagnosed the disease of neuropathy pain arising from diabetic peripheral neuropathy, postherpetic neuralgia, traumatic/surgical nerve injury, incomplete spinal cord injury, or trigeminal neuralgia and if they have a mean weekly pain score of at least 4 on the 100-mm visual analog scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ) completed a screening / baseline period before randomization. Additional disease-specific inclusion criteria are listed in Table 1.
- Subjects must be 20 years of age or older.
Who cannot join
- Subjects who are pregnant, lactating or of childbearing potential not using effective contraceptives.
- Subjects who have a clinically significant or unstable medical or psychiatric condition.
- Subjects who are known of hypersensitivity to Gabapentin.
- Serum creatinine > 1.5 times the upper limit of normal
- Subjects who have received nerve blocks or acupuncture for pain relief within four weeks before a screening / baseline period.
- Subjects who have the presence of chronic pain other than the target pain being studied (unless the chronic pain is in a different body region than the target pain and its intensity is not greater than that of the target pain).
- Subjects who have received nondrug therapies or any special procedures for the relief of the target pain within two weeks before a baseline visit.
- Subjects who are using the following agents within 30 days prior to screening: antidepressants, opioids, other anticonvulsants, local anaesthetic injections or any investigational drug.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the efficacy of Gabapentin (Carbatin \& Neurontin) in patients with neuropathy pain.
- Conditions
- Neuropathy, Pain
- Being tested
- Carbatin, Neurontin
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbatinDrug
Carbatin® or Neurontin® is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days.
The dose of Carbatin® or Neurontin® taken by each patient will amount to 100 to 2400 mg /day oral if the pain intensity reaches a VAS score ≧4. The maintenance dose of Carbatin® or Neurontin® will throughout for at least 14 days of the treatment period.
NeurontinDrug
Carbatin® or Neurontin® is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days.
The dose of Carbatin® or Neurontin® taken by each patient will amount to 100 to 2400 mg /day oral if the pain intensity reaches a VAS score ≧4. The maintenance dose of Carbatin® or Neurontin® will throughout for at least 14 days of the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Carbatin | Experimental | Carbatin is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days Receives: Drug: Carbatin |
| Neurontin | Active comparator | Neurontin is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days Receives: Drug: Neurontin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain intensity using the visual analog scale (VAS)
Measured: up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startMar 2009
- Primary completionJun 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuropathyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nang Kuang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Taichung Veterans General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074267
- Sponsor's protocol ID
- S08174
- Status last verified
- Jul 2020
- First submitted
- 24 Feb 2014
- Last updated
- 9 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for Assessment of the Efficacy of Gabapentin (Carbatin and Neurontin) in Patients With Neuropathy Pain
- ClinicalTrials.gov ID
- NCT02074267
- Acronym / sponsor ID
- S08174
- Conditions
- Neuropathy, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Nang Kuang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Taichung Veterans General Hospital
- Study start
- Mar 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Feb 2014 (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 assess the efficacy of Gabapentin (Carbatin \& Neurontin) in patients with neuropathy pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbatin | Experimental | Drug: CarbatinCarbatin is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days |
| Neurontin | Active comparator | Drug: NeurontinNeurontin is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who have been diagnosed the disease of neuropathy pain arising from diabetic peripheral neuropathy, postherpetic neuralgia, traumatic/surgical nerve injury, incomplete spinal cord injury, or trigeminal neuralgia and if they have a mean weekly pain score of at least 4 on the 100-mm visual analog scale (VAS) of the Short-Form McGill Pain Questionnaire (SF-MPQ) completed a screening / baseline period before randomization. Additional disease-specific inclusion criteria are listed in Table 1.
- Subjects must be 20 years of age or older.
Key exclusion criteria (8 listed)
- Subjects who are pregnant, lactating or of childbearing potential not using effective contraceptives.
- Subjects who have a clinically significant or unstable medical or psychiatric condition.
- Subjects who are known of hypersensitivity to Gabapentin.
- Serum creatinine > 1.5 times the upper limit of normal
- Subjects who have received nerve blocks or acupuncture for pain relief within four weeks before a screening / baseline period.
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 |
|---|---|---|
| CarbatinCarbatin® or Neurontin® is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days. The dose of Carbatin® or Neurontin® taken by each patient will amount to 100 to 2400 mg /day oral if the pain intensity reaches a VAS score ≧4. The maintenance dose of Carbatin® or Neurontin® will throughout for at least 14 days of the treatment period. | Drug | Carbatin |
| NeurontinCarbatin® or Neurontin® is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days. The dose of Carbatin® or Neurontin® taken by each patient will amount to 100 to 2400 mg /day oral if the pain intensity reaches a VAS score ≧4. The maintenance dose of Carbatin® or Neurontin® will throughout for at least 14 days of the treatment period. | Drug | Neurontin |
Primary outcome
Evaluation of pain intensity using the visual analog scale (VAS)
Time frame: up to six 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 9 Nov 2023.
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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 4 study testing Carbatin and Neurontin in people with Neuropathy and Pain, run by Nang Kuang Pharmaceutical Co., Ltd. at 1 site in Taiwan.
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 2 inclusion and 8 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 9 Nov 2023. 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluation of pain intensity using the visual analog scale (VAS) (time frame: up to six 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 9 Nov 2023.