Diabetic Peripheral NeuropathyPhase 2NCT00891683
Safety and Efficacy of AEG33773 Versus Placebo in Patients With Painful Diabetic Peripheral Neuropathy
A Phase 2 study testing AEG33773 oral dosing in people with Diabetic Peripheral Neuropathy and Chronic Pain, run by Aegera Therapeutics at 20 sites in 4 countries.
Trial summary
Two Phase 1 studies have been conducted with AEG33773 and available safety and tolerability data from these studies support further clinical development of AEG33773. The current study is proposed as a proof-of-concept study to assess the potential analgesic efficacy of AEG33773 to reduce pain associated with chronic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy, Chronic Pain
- What is being tested?
- AEG33773 oral dosing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 20 sitesin 4 countries
- Study dates
- Mar 2009to Feb 2010
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age 18 to 75 years
- Patients with type 1 or type 2 diabetes mellitus
- DPN as determined by the investigator based on clinical history, clinical examination, and assessment of signs and symptoms
- Stable diabetic control over the preceding 3 months, as determined by the investigator based on available medical information (e.g., hemoglobin A1c [HbA1c] and/or blood glucose levels)
- HbA1c ≤ 12 % at the Screening visit
- Pain persisting for more than 3 months and less than 5 years
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- Completion of 3 daily pain intensity reports (using the 11-point NPRS) over the 3 days immediately preceding the day of randomization
- Pain intensity (NPRS) score of ≥ 5 for all 3 of the 3 days immediately preceding the day of randomization
- Completed a washout (before first NPRS assessment) of at least 7 days for any of the following medications: α2-δ antagonists (e.g., gabapentin, pregabalin), opiate analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), topical lidocaine, anti-epileptic drugs, serotonin and norepinephrine reuptake inhibitors (SNRIs) (e.g., duloxetine), tricyclic antidepressants prescribed for pain, skeletal muscle relaxants, orally administered steroids, capsaicin, mexiletene, centrally acting analgesics (dextromethorphan, tramadol), alpha lipoic acid, and any supplement or herbal product used to treat DPN symptoms
- Women must be neither pregnant nor lactating. Women of childbearing age must have a confirmed negative pregnancy test and must practice medically acceptable methods of contraception throughout the trial and for at least 30 days after the last dose of study drug
- Male subjects and/or their female partners must be using medically acceptable methods of contraception for the entire duration of the study, and for at least 90 days after the last study drug dose
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
- A willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Who cannot join
- Age younger than 18 years or older than 75 years
- Are pregnant or breast feeding
- Female patients of childbearing potential unwilling to use a medically acceptable form of contraception (i.e., hormonal birth control, intrauterine device [IUD], double barrier [male condom or female condom with a diaphragm], or a barrier method plus a spermicidal agent [contraceptive foam, jelly, or cream]) Female patients are considered to be of childbearing potential unless they have been postmenopausal for at least 1 year, are biologically sterile, or are surgically sterile (history of hysterectomy, bilateral oophorectomy, or bilateral tubal ligation.
- Male patients (and/or their female partners) unwilling to use a medically acceptable form of contraception during participation in the study and for at least 90 days after the last dose of study drug. Medically acceptable forms of contraception are hormonal birth control, intrauterine device (IUD), double barrier (male condom or female condom with a diaphragm), or a barrier method plus a spermicidal agent (contraceptive foam, jelly, or cream)
- Treatment with local anesthetic nerve blocks within the last 30 days before the Screening visit
- Other severe pain which may impair the self-assessment of pain due to DPN
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- Participation in another study within 30 days before the Screening visit and/or during study participation
- History of drug or alcohol abuse within the past 2 years
- Creatinine clearance < 50 mL/min at the Screening visit
- Malignancy other than basal cell carcinoma and carcinoma in situ within the past 2 years
- History of chronic hepatitis B or C, hepatitis within the past 3 months before the Screening visit, or any history of human immunodeficiency virus (HIV) infection
- Clinically significant hepatic, respiratory, hematological, cardiovascular, renal, or neurological disease, with the exception of diabetic peripheral neuropathy
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times higher than the upper limit of the laboratory normal reference range at the Screening visit
- ECG with a QTcB > 470 ms at the Screening visit or at Baseline (if at either the Screening visit or Baseline the ECG shows a QTcB > 470 ms, then the investigator may immediately repeat the ECG twice and the QTcB value for inclusion/exclusion purposes will be determined by calculating the average of the 3 readings)
- Immunocompromised state
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
Romania7 sites
S.C. Nicodiab SRL
Bucharest, 010496
National Clinical Institute of Diabetes, Nutrition and Metabolic Diseases
Bucharest, 020045
National Institute of Diabetes Nutrition and Metabolic Diseases
Bucharest, 020475
Mosilor Diabetes Mellitus and Obesity Medical
Bucharest, 020859
Emergency Clinical County Hospital Cluj County
Cluj-Napoca, 4000006
St. Spiridon Emergency Clinical County Hospital
Iași, 700111
Medical Center "Dr. Negrisanu" SRL
Timișoara, Transylvania, 300456
United States5 sites
Radiant Research
Cincinnatti, Ohio, 45249
UT Southwestern Medical Center
Dallas, Texas, 75390
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Wells Institute for Health Awareness
Kettering, Ohio, 45429
Neurological Research Institute
Santa Monica, California, 90404
Bulgaria5 sites
Multiprofile Hospital for Active Treatment - Internal Department
Byala, 7100
University Multiprofile Hospital for Active Treatment - Clinic of Endocrinology and Metabolic Diseases
Pleven, 5800
University Multiprofile Hospital for Active Treatment - Clinic of Endocrinology and Metabolic Diseases
Plovdiv, 4002
Multiprofile Hospital for Active Treatment - Therapeutical and Endocrinology Department
Rousse, 7002
University Multiprofile Hospital Treatment Stara Zagora
Stara Zagora, 6003
Canada3 sites
Clinique d'Endocrinologie de l'Outaouais
Hull, Quebec, J8V 2P5
Centre de Recherche Clinique de Laval
Laval, Quebec, H7T 2P5
Hopital de l'Enfant Jesus
Québec, Quebec, G1J 1Z4
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of AEG33773 Versus Placebo in Patients With Painful Diabetic Peripheral Neuropathy
Two Phase 1 studies have been conducted with AEG33773 and available safety and tolerability data from these studies support further clinical development of AEG33773. The current study is proposed as a proof-of-concept study to assess the potential analgesic efficacy of AEG33773 to reduce pain associated with chronic Diabetic Peripheral Neuropathy.
Read the detailed description
Doses of AEG33773 selected for evaluation in this study provide a dose range (i.e., 100-400 mg) that may potentially include both a minimally effective dose and a maximum tolerated dose. Doses up to 400 mg were well tolerated in single- and multiple-dose Phase 1 studies.
Before initiation of treatment with study drug, other analgesic medications will be discontinued during a 7-day Washout Period, and neuropathic pain will be assessed (in the absence of analgesic medication) over the next 3 days (Pain Assessment Period). Pain intensity level during these 3 days will be recorded daily, and only those subjects who meet predefined pain intensity threshold criteria on all 3 days will be eligible to receive study drug. Because pain may increase after analgesic medications have been discontinued, the combined length of the Washout and Pain Assessment Periods is limited in order that subjects who experience increased pain during this time may begin treatment with study drug without undue delay. This design will allow for adequate Baseline pain assessment over 3 days while avoiding a more prolonged period of increasing pain in the absence of analgesic medications.
- Conditions
- Diabetic Peripheral Neuropathy, Chronic Pain
- Being tested
- AEG33773 oral dosing
- Keywords
- Diabetic, peripheral, neuropathy, pain, hyperalgesia, allodynia
- Medical subject headings
- Chronic Pain, Pain, Hyperalgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AEG33773 oral dosingDrug
AEG33773 capsules: subjects will receive a daily dose of either 100 mg, 200 mg, or 400 mg AEG33773. Placebo capsules: subjects will receive a daily dose of placebo (matching test product). Capsules will be taken by mouth, over 28 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 4 Capsules of Placebo Receives: Drug: AEG33773 oral dosing |
| 100 mg | Active comparator | One 100 mg capsule and 3 placebo capsules of AEG33773 Receives: Drug: AEG33773 oral dosing |
| 200 mg | Active comparator | Two 100 mg capsules and two placebo capsules Receives: Drug: AEG33773 oral dosing |
| 400 mg | Active comparator | Four 100 mg AEG33773 capsules Receives: Drug: AEG33773 oral dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the potential efficacy of AEG33773 in reducing chronic pain due to DPN
Measured: 1 year
Secondary outcomes (5)
To evaluate a range of AEG33773 doses that provide efficacy
Measured: 1 year
To determine a minimally effective dose of AEG33773
Measured: 1 year
To determine a maximally tolerated dose of AEG33773
Measured: 1 year
To evaluate the safety and tolerability of AEG33773
Measured: 1 year
To explore AEG33773-dependent pharmacodynamic (PD) effects in blood of patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aegera Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jacques Jolivet, MD, FRCP(C), Study director, Aegera Therapeutics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891683
- Sponsor's protocol ID
- AEG33773-201
- Status last verified
- May 2010
- First submitted
- 30 Apr 2009
- Last updated
- 31 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of AEG33773 Versus Placebo in Patients With Painful Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00891683
- Acronym / sponsor ID
- AEG33773-201
- Conditions
- Diabetic Peripheral Neuropathy, Chronic Pain
- Keywords
- Diabetic, peripheral, neuropathy, pain, hyperalgesia, allodynia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Aegera TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 1 May 2009 (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.
Two Phase 1 studies have been conducted with AEG33773 and available safety and tolerability data from these studies support further clinical development of AEG33773. The current study is proposed as a proof-of-concept study to assess the potential analgesic efficacy of AEG33773 to reduce pain associated with chronic Diabetic Peripheral Neuropathy.
Detailed description
Doses of AEG33773 selected for evaluation in this study provide a dose range (i.e., 100-400 mg) that may potentially include both a minimally effective dose and a maximum tolerated dose. Doses up to 400 mg were well tolerated in single- and multiple-dose Phase 1 studies.
Before initiation of treatment with study drug, other analgesic medications will be discontinued during a 7-day Washout Period, and neuropathic pain will be assessed (in the absence of analgesic medication) over the next 3 days (Pain Assessment Period). Pain intensity level during these 3 days will be recorded daily, and only those subjects who meet predefined pain intensity threshold criteria on all 3 days will be eligible to receive study drug. Because pain may increase after analgesic medications have been discontinued, the combined length of the Washout and Pain Assessment Periods is limited in order that subjects who experience increased pain during this time may begin treatment with study drug without undue delay. This design will allow for adequate Baseline pain assessment over 3 days while avoiding a more prolonged period of increasing pain in the absence of analgesic medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: AEG33773 oral dosing4 Capsules of Placebo |
| 100 mg | Active comparator | Drug: AEG33773 oral dosingOne 100 mg capsule and 3 placebo capsules of AEG33773 |
| 200 mg | Active comparator | Drug: AEG33773 oral dosingTwo 100 mg capsules and two placebo capsules |
| 400 mg | Active comparator | Drug: AEG33773 oral dosingFour 100 mg AEG33773 capsules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female age 18 to 75 years
- Patients with type 1 or type 2 diabetes mellitus
- DPN as determined by the investigator based on clinical history, clinical examination, and assessment of signs and symptoms
- Stable diabetic control over the preceding 3 months, as determined by the investigator based on available medical information (e.g., hemoglobin A1c [HbA1c] and/or blood glucose levels)
- HbA1c ≤ 12 % at the Screening visit
Key exclusion criteria (16 listed)
- Age younger than 18 years or older than 75 years
- Are pregnant or breast feeding
- Female patients of childbearing potential unwilling to use a medically acceptable form of contraception (i.e., hormonal birth control, intrauterine device [IUD], double barrier [male condom or female condom with a diaphragm], or a barrier method plus a spermicidal agent [contraceptive foam, jelly, or cream]) Female patients are considered to be of childbearing potential unless they have been postmenopausal for at least 1 year, are biologically sterile, or are surgically sterile (history of hysterectomy, bilateral oophorectomy, or bilateral tubal ligation.
- Male patients (and/or their female partners) unwilling to use a medically acceptable form of contraception during participation in the study and for at least 90 days after the last dose of study drug. Medically acceptable forms of contraception are hormonal birth control, intrauterine device (IUD), double barrier (male condom or female condom with a diaphragm), or a barrier method plus a spermicidal agent (contraceptive foam, jelly, or cream)
- Treatment with local anesthetic nerve blocks within the last 30 days before the Screening visit
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 |
|---|---|---|
| AEG33773 oral dosingAEG33773 capsules: subjects will receive a daily dose of either 100 mg, 200 mg, or 400 mg AEG33773. Placebo capsules: subjects will receive a daily dose of placebo (matching test product). Capsules will be taken by mouth, over 28 consecutive days | Drug | 100 mg, 200 mg, 400 mg, Placebo |
Primary outcome
To evaluate the potential efficacy of AEG33773 in reducing chronic pain due to DPN
Time frame: 1 year
5 secondary outcomes
To evaluate a range of AEG33773 doses that provide efficacy
Time frame: 1 year
To determine a minimally effective dose of AEG33773
Time frame: 1 year
To determine a maximally tolerated dose of AEG33773
Time frame: 1 year
To evaluate the safety and tolerability of AEG33773
Time frame: 1 year
To explore AEG33773-dependent pharmacodynamic (PD) effects in blood of patients
Time frame: 1 year
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 31 May 2010.
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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.
Jacques Jolivet, MD, FRCP(C) study director
Aegera Therapeutics, Inc
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AEG33773 oral dosing in people with Diabetic Peripheral Neuropathy and Chronic Pain, run by Aegera Therapeutics at 20 sites in 4 countries.
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 13 inclusion and 16 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 31 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Romania, United States, Bulgaria, Canada. 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. Some participants in this study may receive a placebo. 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 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?
To evaluate the potential efficacy of AEG33773 in reducing chronic pain due to DPN (time frame: 1 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 31 May 2010.