Chronic Peripheral Neuropathy Pain in DiabeticsPhase 2NCT00597649
A 52-Week Study of Bicifadine in Patients With Chronic Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
A Phase 2 study testing Bicifadine in people with Chronic Peripheral Neuropathy Pain in Diabetics, run by XTL Biopharmaceuticals at 1 site in United States.
Trial summary
This study is to evaluate the long-term efficacy and safety of two dosages of bicifadine SR (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy pain due to diabetes in adult outpatients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Peripheral Neuropathy Pain in Diabetics
- What is being tested?
- Bicifadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2008
- Phase
- Phase 2
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- 18 years or older
- Diagnosis of type 1 or type 2 non-insulin dependent diabetes mellitus
- Chronic bilateral pain due to diabetic neuropathy, pain for at least six months.
- Primary pain is located in the feet.
- Subject participated in and completed the XTL 07-001 clinical trial.
- Contact site for additional information.
Who cannot join
- Symptoms of other painful conditions
- Presence of amputations other than toes
- Clinically significant psychiatric or other neuropsychological disorder
- Use of certain medications
- Clinically important other diseases
- Pregnancy
- History of alcohol or narcotic abuse within two years.
- Contact site for additional information.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label 52-Week Safety Study of Bicifadine SR in Adult Outpatients With Chronic Peripheral Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
This study is to evaluate the long-term efficacy and safety of two dosages of bicifadine SR (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy pain due to diabetes in adult outpatients.
- Being tested
- Bicifadine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BicifadineDrug
SR dosage form of 400 mg bid or tid for one year
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bicifadine 800 mg/day for a year Receives: Drug: Bicifadine |
| 2 | Experimental | Bicifadine 1200 mg/day for a year Receives: Drug: Bicifadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain and safety
Measured: one year
Secondary outcomes (1)
Clinical Global Impression of Improvement; McGill Pain Questionnaire; Amount of Rescue Medication Used for Pain; Quality of Life Survey (SF-36); Patient Global Impression of Change
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: The 001 trial did not show benefit versus placebo
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Peripheral Neuropathy Pain in DiabeticsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- XTL Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Roffman, PhD, Study director, XTL Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597649
- Sponsor's protocol ID
- XTL B07-002
- Other IDs
- 2007-003638-40
- Status last verified
- Jun 2009
- First submitted
- 9 Jan 2008
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label 52-Week Safety Study of Bicifadine SR in Adult Outpatients With Chronic Peripheral Neuropathic Pain Associated With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00597649
- Acronym / sponsor ID
- XTL B07-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The 001 trial did not show benefit versus placebo
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- XTL BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 18 Jan 2008 (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.
This study is to evaluate the long-term efficacy and safety of two dosages of bicifadine SR (600 mg/day and 1200 mg/day) for up to 52 weeks in reducing chronic peripheral neuropathy pain due to diabetes in adult outpatients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BicifadineBicifadine 800 mg/day for a year |
| 2 | Experimental | Drug: BicifadineBicifadine 1200 mg/day for a year |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female
- 18 years or older
- Diagnosis of type 1 or type 2 non-insulin dependent diabetes mellitus
- Chronic bilateral pain due to diabetic neuropathy, pain for at least six months.
- Primary pain is located in the feet.
Key exclusion criteria (8 listed)
- Symptoms of other painful conditions
- Presence of amputations other than toes
- Clinically significant psychiatric or other neuropsychological disorder
- Use of certain medications
- Clinically important other diseases
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 |
|---|---|---|
| BicifadineSR dosage form of 400 mg bid or tid for one year | Drug | 1, 2 |
Primary outcome
Pain and safety
Time frame: one year
1 secondary outcome
Clinical Global Impression of Improvement; McGill Pain Questionnaire; Amount of Rescue Medication Used for Pain; Quality of Life Survey (SF-36); Patient Global Impression of Change
Time frame: One year
Results and safety
The study was stopped early (reason given: The 001 trial did not show benefit versus placebo). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2009.
- Sponsor's websiteLink provided by the sponsor.
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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.
Mark Roffman, PhD study director
XTL Biopharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bicifadine in people with Chronic Peripheral Neuropathy Pain in Diabetics, run by XTL Biopharmaceuticals at 1 site in United States.
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 7 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: stopped early, as of the sponsor's last update on 30 Jun 2009. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: The 001 trial did not show benefit versus placebo). Results are not available in the source record.
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?
Pain and safety (time frame: one year). 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 30 Jun 2009.