Diabetic Neuropathy, PainfulPhase 3NCT00058968
A Study for the Treatment of Painful Diabetic Neuropathy
A Phase 3 study testing Duloxetine hydrochloride in people with Diabetic Neuropathy, Painful, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy, Painful
- What is being tested?
- Duloxetine hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 660 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Mar 2005
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients at least 18 years of age.
- Patients with pain due to diabetic neuropathy in both legs.
- Females must not be pregnant or plan to become pregnant during the study.
- Stable Glycemic control.
- Average mean pain severity score of at least 4.0 as assessed by completion of a daily diary.
Who cannot join
- You are related to or work for the physician conducting the study or are employed by Eli Lilly and Company.
- You have a severe or serious medical condition that causes you to be hospitalized often; or you have had a kidney transplant or are on current dialysis.
- You have participated in a study for an investigational drug within the last 30 days.
- You have a history of major depressive disorder, generalized anxiety disorder, or alcohol or eating disorders.
- You have a past medical history or diagnosis of mania, bipolar disorder, or psychosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLilly (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pembroke Pines, Florida
About this study
Official title: Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy
The purpose of the study is to determine if duloxetine can help patients with painful diabetic neuropathy.
Read the detailed description
The protocol will assess the efficacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.
- Conditions
- Diabetic Neuropathy, Painful
- Being tested
- Duloxetine hydrochloride, placebo
- Keywords
- neuropathy, pain, diabetes, chronic pain, persistent pain, leg pain, peripheral neuropathy, foot pain, painful neuropathy, diabetic neuropathy
- Medical subject headings
- Diabetic Neuropathies, Pain, Diabetes Mellitus, Chronic Pain, Peripheral Nervous System Diseases, Neuropathy, Painful
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine hydrochlorideDrug
placeboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in average pain severity as measured by an 11-point Likert scale.
Secondary outcomes (7)
Pain severity for worst pain and night pain as measured by an 11-point Likert scale.
Clinical Global Impression of Severity scale to measure severity of illness at the time of assessment.
Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment.
Brief Pain Inventory to measure the severity of pain.
Sensory Portion of the Short Form McGill pain questionnaire measures severity of 11 pain descriptors.
Hamilton Depression Rating Scale (17 item) used to assess severity of depression symptoms during the course of therapy.
Dynamic Allodynia measure to elicit the pain severity to a normally non-painful stimulus.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2003 (estimated)
- Study startOct 2002
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Neuropathy, PainfulStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 660 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058968
- Sponsor's protocol ID
- 4097
- Other IDs
- F1J-MC-HMAV
- Status last verified
- May 2007
- First submitted
- 15 Apr 2003
- Last updated
- 17 May 2007
- Results posted
- No
Publications
Ziegler D, Pritchett YL, Wang F, Desaiah D, Robinson MJ, Hall JA, Chappell AS. Impact of disease characteristics on the efficacy of duloxetine in diabetic peripheral neuropathic pain. Diabetes Care. 2007 Mar;30(3):664-9. doi: 10.2337/dc06-2009.
PubMed 17327338
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine Versus Placebo in the Treatment of Patients With Painful Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00058968
- Acronym / sponsor ID
- 4097
- Conditions
- Diabetic Neuropathy, Painful
- Keywords
- neuropathy, pain, diabetes, chronic pain, persistent pain, leg pain, peripheral neuropathy, foot pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 660 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Study completion
- Mar 2005 (actual)
- First posted
- 16 Apr 2003 (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 the study is to determine if duloxetine can help patients with painful diabetic neuropathy.
Detailed description
The protocol will assess the efficacy and safety of duloxetine. It will also look at how duloxetine affects quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female outpatients at least 18 years of age.
- Patients with pain due to diabetic neuropathy in both legs.
- Females must not be pregnant or plan to become pregnant during the study.
- Stable Glycemic control.
- Average mean pain severity score of at least 4.0 as assessed by completion of a daily diary.
Key exclusion criteria (5 listed)
- You are related to or work for the physician conducting the study or are employed by Eli Lilly and Company.
- You have a severe or serious medical condition that causes you to be hospitalized often; or you have had a kidney transplant or are on current dialysis.
- You have participated in a study for an investigational drug within the last 30 days.
- You have a history of major depressive disorder, generalized anxiety disorder, or alcohol or eating disorders.
- You have a past medical history or diagnosis of mania, bipolar disorder, or psychosis.
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 |
|---|---|---|
| Duloxetine hydrochloride | Drug | – |
| placebo | Drug | – |
Primary outcome
Reduction in average pain severity as measured by an 11-point Likert scale.
7 secondary outcomes
Pain severity for worst pain and night pain as measured by an 11-point Likert scale.
Clinical Global Impression of Severity scale to measure severity of illness at the time of assessment.
Patient Global Impression of Improvement scale to measure the degree of improvement at the time of assessment.
Brief Pain Inventory to measure the severity of pain.
Sensory Portion of the Short Form McGill pain questionnaire measures severity of 11 pain descriptors.
Hamilton Depression Rating Scale (17 item) used to assess severity of depression symptoms during the course of therapy.
Dynamic Allodynia measure to elicit the pain severity to a normally non-painful stimulus.
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 17 May 2007.
- Derived from this study: PubMed 17327338Ziegler D, Pritchett YL, Wang F, Desaiah D, Robinson MJ, Hall JA, Chappell AS. Impact of disease characteristics on the efficacy of duloxetine in diabetic peripheral neuropathic pain. Diabetes Care. 2007 Mar;30(3):664-9. doi: 10.2337/dc06-2009.
- Lilly Clinical Trial RegistryLink 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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours EST) study director
Eli Lilly and Company
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 Duloxetine hydrochloride in people with Diabetic Neuropathy, Painful, run by Eli Lilly and Company 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 5 inclusion and 5 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 17 May 2007. 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 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?
Reduction in average pain severity as measured by an 11-point Likert scale.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00058968, which also lists 1 linked publication.
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 17 May 2007.