Three Way Interaction Between Gabapentin, Duloxetine, and Donepezil in Patients With Diabetic Neuropathy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to determine whether the combination of the the three drugs gabapentin, duloxetine, and donepezil are effective in treating pain in people with diabetic neuropathy or patients with failed low back syndrome (chronic back pain).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study in Painful Diabetic Neuropathy

NCT01089556

Diabetic Neuropathy, Painful

COMPLETED PHASE3

An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain

NCT00385671

Diabetic Neuropathy, Painful

COMPLETED PHASE4

A Study of Duloxetine (LY248686) in Participants With Diabetic Peripheral Neuropathic Pain (DPNP)

NCT02417935

Diabetic Peripheral Neuropathic Pain

COMPLETED PHASE4

Safety and Efficacy Study in Subjects With Diabetic Neuropathic Pain

NCT00507936

Diabetic Neuralgia Diabetic Neuropathies Diabetic Neuropathy, Painful +2 more

COMPLETED PHASE2

A Study Comparing the Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain

NCT01579279

Diabetic Neuropathic Pain

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Neuropathic pain is a complex and likely heterogeneous disorder, and we recognize that clinically useful agents such as opioids, gabapentin, and antidepressants may be effective precisely because they have multiple mechanisms of action at multiple sites. This study, however, will not only provide important mechanistic information regarding one cascade which can be manipulated for analgesia, but will also provide much needed systematic and practical guidance for multi-drug therapy in patients with neuropathic pain.

This study in patients with diabetic neuropathic pain and patients with failed low back syndrome, culminate in a quantitative description of interactions between activators of descending noradrenergic activity, norepinephrine transporter inhibitors, and cholinesterase inhibitors to exploit the plasticity of analgesia in chronic pain states. We will focus on practical applications, using clinically approved drugs, including gabapentin (Neurontin®) to activate noradrenergic activity, duloxetine (Cymbalta®) to inhibit the norepinephrine transporter, and donepezil (Aricept®), approved for the treatment of Alzheimer's dementia, but not previously tested to treat neuropathic pain, to inhibit cholinesterase.

After the baseline measurements and physical examination patients will be trained to use a Personal Digital Assistant (PDA) to answer questions about their diabetic neuropathic pain or their chronic back pain. Upon successful completion of these tasks the patients will be randomized to receive one of the drug choices or placebo (inactive pill).

The study will last for a total of 16 weeks and includes 5 visits to the research center with each visit lasting approximately 2 hours.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Neuropathic Pain Chronic Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Donepezil

Donepezil 5 mg once per day for 12 weeks. Gabapentin will be titrated in all groups beginning at week 8.

Group Type ACTIVE_COMPARATOR

donepezil

Intervention Type DRUG

Group 1: Will receive donepezil 5mg once a day

gabapentin

Intervention Type DRUG

Week 8: all subjects will have open label gabapentin added to their randomized study medication

Duloxetine

Group 2: Will receive duloxetine 30 mg twice a day for 12 weeks. Gabapentin will be titrated in all groups beginning at week 8.

Group Type ACTIVE_COMPARATOR

duloxetine

Intervention Type DRUG

Group 2: Will receive duloxetine 30 mg twice a day

gabapentin

Intervention Type DRUG

Week 8: all subjects will have open label gabapentin added to their randomized study medication

Donepezil + Duloxetine

Group 3: Will receive a combination of donepezil 2.5 mg and duloxetine 30mg for 12 weeks. Gabapentin will be titrated in all groups beginning at week 8.

Group Type ACTIVE_COMPARATOR

donepezil 2.5 mg and duloxetine 30mg

Intervention Type DRUG

Group 3: Will receive a combination of donepezil 2.5 mg and duloxetine 30mg

gabapentin

Intervention Type DRUG

Week 8: all subjects will have open label gabapentin added to their randomized study medication

Placebo

Group 4:Will receive placebo pills. Gabapentin will be titrated in all groups beginning at week 8.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Group 4: Will receive placebo pills

gabapentin

Intervention Type DRUG

Week 8: all subjects will have open label gabapentin added to their randomized study medication

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

donepezil

Group 1: Will receive donepezil 5mg once a day

Intervention Type DRUG

duloxetine

Group 2: Will receive duloxetine 30 mg twice a day

Intervention Type DRUG

donepezil 2.5 mg and duloxetine 30mg

Group 3: Will receive a combination of donepezil 2.5 mg and duloxetine 30mg

Intervention Type DRUG

placebo

Group 4: Will receive placebo pills

Intervention Type DRUG

gabapentin

Week 8: all subjects will have open label gabapentin added to their randomized study medication

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Aricept® Cymbalta® Cymbalta® Aricept® neurontin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of diabetic neuropathy
* Age 18-80
* Willing to temporarily discontinue gabapentin or monoamine reuptake inhibitors upon entry into the study

Exclusion Criteria

* Pregnancy
* Allergy to study medications
* Uncontrolled narrow-angle glaucoma
* Currently being treatment with thioridazine (Mellaril)
* Unstable medical conditions including cardiac, pulmonary, renal or hepatic diseases
* Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days of randomization

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No