Diabetic NeuropathiesPhase 3NCT00408993

Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China

A Phase 3 study testing Duloxetine Hydrochloride in people with Diabetic Neuropathies, run by Eli Lilly and Company at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic Neuropathy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Neuropathies
What is being tested?: Duloxetine Hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 215 participants
Where: 7 sitesChina
Study dates: Dec 2006to Feb 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.
May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.

Who cannot join

Glycosylated hemoglobin (A1C) > 12%
Severe hepatic disease
History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis), kidney, respiratory, blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or likely to lead to hospitalization during the course of the study.
Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.
Treatment of fluoxetine within 30 days of starting the study.
Unstable blood sugar control and uncontrolled or poorly controlled hypertension.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

China7 sites

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.
Beijing, 100101
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.
Changsha, 410011
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.
Harbin, 150086
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.
Nanjin, 210012
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.
Nanjing, 210029
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.
Shanghai, 200233
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.
Wuhan, 430022

Other trials in China

About this study

To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic Neuropathy.

Conditions: Diabetic Neuropathies
Being tested: Duloxetine Hydrochloride, Placebo
Medical subject headings: Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Duloxetine HydrochlorideDrug
Also called LY248686, Cymbalta
60 mg every day (QD) (morning or evening), by mouth (PO)
PlaceboDrug
Placebo every day (QD), by mouth (PO)

Study groups in NCT00408993
Study group	Role	What they receive
Duloxetine	Experimental	60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response) Receives: Drug: Duloxetine Hydrochloride
Placebo	Placebo comparator	Placebo every day (QD), by mouth (PO) for 12 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Measured: Baseline and 12 weeks

Secondary outcomes (12)

Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores
Measures severity of pain and interference of pain on function. Each severity of pain (worst, least, and current) scores range from 0 (no pain) to 10 (pain as severe as you can imagine). The 7 separate Interference item scores range from 0 (does not interfere) to 10 (completely interferes) and were averaged to provide a single score (0 to 10).
Measured: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.
Measured: Baseline and 12 weeks
Time Course of Change in Patient Global Impression - Improvement Scale
A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse).
Measured: baseline, over 12 weeks
Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score)
The EQ-5D is an assessment of one's overall health. Consists of 5 items. Patients choose 1 of 3 options that best describe the status of each item. The EQ-5D US based index scores range from -0.11 to 1.0 where a score of 1.0 indicates perfect health. A positive change from baseline indicates health improvement.
Measured: Baseline and 12 weeks
Number of Participants Discontinuing Due to Adverse Events
Measured: over 12 weeks
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Tolerability of morning versus evening dosing, as assessed by the number of participants with spontaneously reported adverse events.
Measured: over 12 weeks
Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item
Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version (sum of items 1-8) ranges from 0-24, while total score of the 5-item (sum of items 1-5) ranges from 0-15.
Measured: Baseline and 12 weeks
Vital Signs - Weight
Change from baseline to endpoint in body weight.
Measured: Baseline and 12 weeks
Vital Signs - Pulse Rate
Change from baseline to endpoint in pulse rate.
Measured: Baseline and 12 weeks
Vital Signs - Blood Pressure
Change from baseline to endpoint in systolic and diastolic blood pressure.
Measured: Baseline and 12 weeks
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides
Significantly different laboratory values between the two groups in baseline to endpoint changes in chloride, high density lipoprotein, sodium, and triglycerides.
Measured: Baseline and 12 weeks
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid
Significantly different laboratory values between the two groups in baseline to endpoint changes
Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2006Feb 2008

First posted8 Dec 2006 (estimated)
Study startDec 2006
Primary completionFeb 2008
Study completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetic NeuropathiesStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 215 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00408993
Sponsor's protocol ID: 10599
Other IDs: F1J-MC-HMEQ(a)
Status last verified: Jul 2011
First submitted: 6 Dec 2006
Last updated: 26 Jul 2011
Results posted: Yes, on ClinicalTrials.gov

Publications

Gao Y, Ning G, Jia WP, Zhou ZG, Xu ZR, Liu ZM, Liu C, Ma JH, Li Q, Cheng LL, Wen CY, Zhang SY, Zhang Q, Desaiah D, Skljarevski V. Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China. Chin Med J (Engl). 2010 Nov;123(22):3184-92.
PubMed 21163113

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)

All Diabetic Neuropathies trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China
ClinicalTrials.gov ID: NCT00408993
Acronym / sponsor ID: 10599
Conditions: Diabetic Neuropathies
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 215 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Boehringer Ingelheim
Study start: Dec 2006
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 8 Dec 2006 (estimated)
Results: Posted 2 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic Neuropathy.

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
Duloxetine	Experimental	Drug: Duloxetine Hydrochloride60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
Placebo	Placebo comparator	Drug: PlaceboPlacebo every day (QD), by mouth (PO) for 12 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.
May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.

Key exclusion criteria (7 listed)

Glycosylated hemoglobin (A1C) > 12%
Severe hepatic disease
History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis), kidney, respiratory, blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or likely to lead to hospitalization during the course of the study.
Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.

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 HydrochlorideAlso: LY248686, Cymbalta60 mg every day (QD) (morning or evening), by mouth (PO)	Drug	Duloxetine
PlaceboPlacebo every day (QD), by mouth (PO)	Drug	Placebo

Primary outcome

Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score
Time frame: Baseline and 12 weeks
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).

12 secondary outcomes

Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores
Time frame: Baseline and 12 weeks
Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity
Time frame: Baseline and 12 weeks
Time Course of Change in Patient Global Impression - Improvement Scale
Time frame: baseline, over 12 weeks
Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score)
Time frame: Baseline and 12 weeks
Number of Participants Discontinuing Due to Adverse Events
Time frame: over 12 weeks
Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)
Time frame: over 12 weeks
Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item
Time frame: Baseline and 12 weeks
Vital Signs - Weight
Time frame: Baseline and 12 weeks
Vital Signs - Pulse Rate
Time frame: Baseline and 12 weeks
Vital Signs - Blood Pressure
Time frame: Baseline and 12 weeks
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides
Time frame: Baseline and 12 weeks
Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 2 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Duloxetine	106	87
Placebo	109	92

Primary outcome: Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score

Time frame: Baseline and 12 weeks. Least squares mean (Standard Error). Unit: units on a scale

Measure	Duloxetine n = 104	Placebo n = 109
Value	-2.69 (0.19)	-2.31 (0.18)

Duloxetine vs Placebo: p = 0.617, ANCOVA

Population analysed: Intention to Treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline value.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of ?	77 of ?	Not reported
Duloxetine 60/120 mg QD	2 of ?	85 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21163113Gao Y, Ning G, Jia WP, Zhou ZG, Xu ZR, Liu ZM, Liu C, Ma JH, Li Q, Cheng LL, Wen CY, Zhang SY, Zhang Q, Desaiah D, Skljarevski V. Duloxetine versus placebo in the treatment of patients with diabetic neuropathic pain in China. Chin Med J (Engl). 2010 Nov;123(22):3184-92.

Related trials for Diabetic Neuropathies

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)

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 from 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

7 sites 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 Neuropathies, run by Eli Lilly and Company at 7 sites in China.

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 3 inclusion and 7 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 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. 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 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?

Yes. Results are posted in the registry (first posted 2 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score (time frame: Baseline and 12 weeks). 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 NCT00408993, 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 26 Jul 2011.