Diabetic Peripheral NeuropathyPhase 2NCT00476151

A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy

A Phase 2 study testing EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream in people with Diabetic Peripheral Neuropathy and Neuralgia, run by EpiCept Corporation at 1 site in India.

Completed

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

Official record

Search all trials

Trial summary

This is a multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with pain in the lower extremities due to diabetic nerve pain. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Peripheral Neuropathy, Neuralgia
What is being tested?: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 226 participants
Where: 1 siteIndia
Study dates: Jul 2007to Apr 2008
Phase: Phase 2
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

Adult patients with chronic pain due to diabetic peripheral neuropathy (DPN) of at least 6 months duration are eligible if they have an average daily pain score of > 4 during the baseline week.

Who cannot join

Clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, skeletal) that the investigator determines could interfere with the efficacy or safety assessments in this study

Trial locations and contacts

1 site in 1 country.

India1 site

Multiple Centers
New Delhi

Other trials in India

About this study

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of EpiCept™ NP-1 Topical Cream in Patients With Pain From Diabetic Peripheral Neuropathy (DPN)

Read the detailed description

This is a phase II, multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with chronic pain in the lower extremities due to diabetic peripheral neuropathy (DPN).

Conditions: Diabetic Peripheral Neuropathy, Neuralgia
Being tested: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream, placebo cream
Keywords: DPN, Diabetic, Nerve Pain
Medical subject headings: Neuralgia

What participants receive

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

EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical CreamDrug
Also called EpiCept NP-1
topical cream applied daily for 4 weeks
placebo creamDrug
inactive placebo cream applied two times daily

Study groups in NCT00476151
Study group	Role	What they receive
placebo cream	Placebo comparator	vehicle cream Receives: Drug: placebo cream
amitriptyline 4% ketamine 2% cream	Active comparator	active topical cream Receives: Drug: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream

What is being measured

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

Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.
diabetic peripheral neuropathy (DPN) pain is recorded on a numerical rating scale of 0 (no pain) to 10 (worst possible pain) at baseline and the endpoint of 4 weeks.
Measured: baseline and 4 weeks treatment

Timeline

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

Jul 2007Apr 2008

First posted21 May 2007 (estimated)
Study startJul 2007
Primary completionApr 2008
Study completionApr 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.
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: 226 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00476151
Sponsor's protocol ID: EPC2006-01
Status last verified: Apr 2011
First submitted: 17 May 2007
Last updated: 17 May 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

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
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)

All Diabetic Peripheral Neuropathy trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of EpiCept™ NP-1 Topical Cream in Patients With Pain From Diabetic Peripheral Neuropathy (DPN)
ClinicalTrials.gov ID: NCT00476151
Acronym / sponsor ID: EPC2006-01
Conditions: Diabetic Peripheral Neuropathy, Neuralgia
Keywords: DPN, Diabetic, Nerve Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 226 participants (actual)
Lead sponsor: EpiCept CorporationIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 21 May 2007 (estimated)
Results: Posted 17 May 2011

Clinical summary

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

Detailed description

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
placebo cream	Placebo comparator	Drug: placebo creamvehicle cream
amitriptyline 4% ketamine 2% cream	Active comparator	Drug: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Creamactive topical cream

Who may qualify

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

Key inclusion criteria (1 listed)

Adult patients with chronic pain due to diabetic peripheral neuropathy (DPN) of at least 6 months duration are eligible if they have an average daily pain score of > 4 during the baseline week.

Key exclusion criteria (1 listed)

Clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, skeletal) that the investigator determines could interfere with the efficacy or safety assessments in this 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
EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical CreamAlso: EpiCept NP-1topical cream applied daily for 4 weeks	Drug	amitriptyline 4% ketamine 2% cream
placebo creaminactive placebo cream applied two times daily	Drug	placebo cream

Primary outcome

Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.
Time frame: baseline and 4 weeks treatment
diabetic peripheral neuropathy (DPN) pain is recorded on a numerical rating scale of 0 (no pain) to 10 (worst possible pain) at baseline and the endpoint of 4 weeks.

Results and safety

Results posted to the registry on 17 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Cream	112	109
Amitriptyline 4% Ketamine 2% Cream	114	107

Primary outcome: Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.

Time frame: baseline and 4 weeks treatment. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Placebo Cream n = 108	Amitriptyline 4% Ketamine 2% Cream n = 106
Value	1.64 (1.21 to 2.06)	2.12 (1.72 to 2.53)

Placebo Cream vs Amitriptyline 4% Ketamine 2% Cream: p = 0.083, ANCOVA

Population analysed: ITT (Intention To Treat) completer population, LOCF (Last Observation Carried Forward) imputation

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Cream	0 of 112 (0%)	16 of 112 (14.3%)	Not reported
Amitriptyline 4% Ketamine 2% Cream	0 of 114 (0%)	17 of 114 (14.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Peripheral Neuropathy

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
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength 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.

Robert H Dworkin, Ph.D. principal investigator

University of Rochester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream in people with Diabetic Peripheral Neuropathy and Neuralgia, run by EpiCept Corporation at 1 site in India.

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 1 inclusion and 1 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 2011. 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 India. 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?

Yes. Results are posted in the registry (first posted 17 May 2011). 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?

Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks. (time frame: baseline and 4 weeks treatment). 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 NCT00476151.

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 2011.