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

NCT00619983 | Terminated Phase 4 Results DMC FDA Drug

• 2 other identifiers: IRB000039435R01NS057594
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Diabetic Neuropathic Pain; Chronic Low Back Pain

Keywords

Asymmetric Diabetic Proximal Motor Neuropathy; Diabetic Autonomic Neuropathy; Diabetic Neuralgia; Diabetic Neuropathy, Painful; Neuralgia, Diabetic; Low back pain, chronic

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale for Pain

  The primary outcome measure is the visual analog scale (VAS) for pain, a 10 cm line upon which the subject marks their intensity of pain. The line is anchored on the left as "No pain at all" and on the right as "The worst pain imaginable". The score is the number of millimeters from the left origin of the line. The primary outcome measure for each period was the average value of all assessments for that period (2 weeks of measures for baseline, 6 weeks of measures for test drug alone, 6 weeks of measures for test drug plus gabapentin, and 2 weeks of measures for gabapentin alone).

  Study completion (16 weeks)

Study Arms (4)

Donepezil

ACTIVE COMPARATOR

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

Drug: donepezil; Drug: gabapentin

Duloxetine

ACTIVE COMPARATOR

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

Drug: duloxetine; Drug: gabapentin

Donepezil + Duloxetine

ACTIVE COMPARATOR

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.

Drug: donepezil 2.5 mg and duloxetine 30mg; Drug: gabapentin

Placebo

PLACEBO COMPARATOR

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

Drug: placebo; Drug: gabapentin

Interventions

donepezil DRUG

Group 1: Will receive donepezil 5mg once a day

Also known as: Aricept®

Donepezil

duloxetine DRUG

Group 2: Will receive duloxetine 30 mg twice a day

Also known as: Cymbalta®

Duloxetine

donepezil 2.5 mg and duloxetine 30mg DRUG

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

Also known as: Cymbalta®, Aricept®

Donepezil + Duloxetine

placebo DRUG

Group 4: Will receive placebo pills

Placebo

gabapentin DRUG

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

Also known as: neurontin

Donepezil; Donepezil + Duloxetine; Duloxetine; Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (2)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Low Back Pain; Bronchiolitis Obliterans Syndrome

Interventions

Donepezil; Duloxetine Hydrochloride; Gabapentin

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Thiophenes; Sulfur Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

We recruited only a small proportion of the planned enrollment in the period of grant funding, leading to early termination of the study. Also, the failure of the electronic diaries and loss of primary outcome data prevented the planned analysis.

Results Point of Contact

• Title: Dr. James Eisenach
• Organization: Wake Forest School of Medicine

jimeisenach@gmail.com

336-716-4182

Study Officials

• James C Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 11, 2018
• Results First Posted: August 10, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)