Diabetic NeuropathiesPhase 3M-F0434NCT01263132

Neuropathic Pain Management

A Phase 3 study testing F0434 and Gabapentin in people with Diabetic Neuropathies and Polyneuropathies, run by Merck KGaA, Darmstadt, Germany at 1 site in Mexico.

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 prospective, randomized, double blind, comparative, experimental controlled Phase 3 clinical trial to assess the efficacy, safety and superiority of F0343 (gabapentin combined with B vitamins) compared to gabapentin alone for treating neuropathic pain in subjects with chronic distal diabetic polyneuropathy. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Diabetic Neuropathies, Polyneuropathies
What is being tested?: F0434 and Gabapentin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 1 siteMexico
Study dates: Feb 2008to Feb 2010
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects diagnosed with diabetes mellitus type 2
Subjects with a history of neuropathic pain in the last 3 Months
Men and women in reproductive age with a family planning method
Subjects aged between 18 to 70 years
Subjects with glycosylated haemoglobin (HbA1c) greater than 7% and less than 15%
Subjects that obtain a grade equal or greater than 4 in the visual analogue scale during the screening visit

Who cannot join

Subjects diagnosed as being pregnant or in state of lactation
Subjects with serum creatinine greater than 1.2 or creatinine depuration in 24 hour urine, less than 60mL/min
Subjects who are receiving treatment with anti-depressants, anti-epileptics, and are taking vitamin B1 and B12 for treatment of neuropathic diabetes
Subjects who are being pharmacologically treated for epilepsy
Subjects diagnosed with rheumatic and hepatic disease and diagnosed with neuropathy for other causes
Subjects with psychological and psychiatric alteration that hinders adequate collaboration in the study

Show all 12Show fewer

Subjects with any orthopaedic alteration of any extremity
Subjects with peripheral artery disease
Subjects taking more than two neuropathic pain medicines
Subjects with history of alcohol, cocaine, marijuana or benzodiazepine substance abuse
Subjects with acid-peptic disease
Subjects with history of neoplasm of any type

Trial locations and contacts

1 site in 1 country.

Mexico1 site

REMEDI Resultados Médicos Desarrollo e Investigación, S.C.
Pachuca, Hidalgo, 42090

Other trials in Mexico

About this study

Official title: Neuropathic Pain Treatment Using F0434 vs. Gabapentin in Patients With Chronic Distal Diabetic Polyneuropathy: A Randomized, Controlled, Double-blind Study

Read the detailed description

Subjects will be assigned to one of the two arms of the study, after having been deemed eligible during the screening visit in random double-blind design. Subjects will be evaluated for a 4 week period.

OBJECTIVES

To assess the effects of F0434 and gabapentin alone on neuropathic pain and Quality Of Life (QOL) of subjects with diabetic neuropathy through a current and validated neuropathic pain scale along with the QOL questionnaire.

Conditions: Diabetic Neuropathies, Polyneuropathies
Being tested: F0434, Gabapentin
Keywords: Polyneuropathy, Diabetes Mellitus, Diabetic peripheral neuropathy
Medical subject headings: Diabetic Neuropathies, Polyneuropathies, Diabetes Mellitus

What participants receive

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

F0434Drug
Also called Gabapentin with thiamine and cobalamin
F0434 will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2).
GabapentinDrug
Also called Gababion, Gavindo
Gabapentin will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2)

Study groups in NCT01263132
Study group	Role	What they receive
F0434	Experimental	Not described Receives: Drug: F0434
Gabapentin	Active comparator	Not described Receives: Drug: Gabapentin

What is being measured

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

Mean Neuropathic Pain Score at Visit 3 (Week 1)
Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.
Measured: Visit 3 (Week 1)
Mean Neuropathic Pain Score at Visit 4 (Week 2)
Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.
Measured: Visit 4 (Week 2)
Mean Neuropathic Pain Score at Visit 5 (Week 3)
Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.
Measured: Visit 5 (Week 3)
Mean Neuropathic Pain Score at Visit 6 (Week 4)
Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.
Measured: Visit 6 (Week 4)

Secondary outcomes (1)

Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire
SF-36 is a standardized health survey consisting of 36 questions to measure functional health status. Summary scores are calculated using the following 8 dimensions: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is obtained by SF-36 algorithm and it is represented as an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). Higher scores are indicative of a better health status.
Measured: Visit 2 (Baseline) to Visit 6 (Week 4)

Timeline

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

Feb 2008Feb 2010

First posted20 Dec 2010 (estimated)
Study startFeb 2008
Primary completionFeb 2010
Study completionFeb 2010

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 NeuropathiesStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01263132
Sponsor's protocol ID: 200057-500
Acronym: M-F0434
Status last verified: Jan 2014
First submitted: 14 Dec 2010
Last updated: 13 Feb 2014
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

Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
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)
RecruitingObservational study
Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
Diabetic Foot Ulcers (DFUs)
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
Not yet recruitingPhase 1
Placental Cells for Diabetic Foot Ulcers
Diabetic Foot Ulcer

All Diabetic Neuropathies trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neuropathic Pain Treatment Using F0434 vs. Gabapentin in Patients With Chronic Distal Diabetic Polyneuropathy: A Randomized, Controlled, Double-blind Study
ClinicalTrials.gov ID: NCT01263132
Acronym / sponsor ID: M-F0434 / 200057-500
Conditions: Diabetic Neuropathies, Polyneuropathies
Keywords: Polyneuropathy, Diabetes Mellitus, Diabetic peripheral neuropathy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Collaborators: Merck S.A. de C.V., Mexico
Study start: Feb 2008
Primary completion: Feb 2010 (actual)
Study completion: Feb 2010 (actual)
First posted: 20 Dec 2010 (estimated)
Results: Posted 27 Oct 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

OBJECTIVES

To assess the effects of F0434 and gabapentin alone on neuropathic pain and Quality Of Life (QOL) of subjects with diabetic neuropathy through a current and validated neuropathic pain scale along with the QOL questionnaire.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
F0434	Experimental	Drug: F0434
Gabapentin	Active comparator	Drug: Gabapentin

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subjects diagnosed with diabetes mellitus type 2
Subjects with a history of neuropathic pain in the last 3 Months
Men and women in reproductive age with a family planning method
Subjects aged between 18 to 70 years
Subjects with glycosylated haemoglobin (HbA1c) greater than 7% and less than 15%

Key exclusion criteria (12 listed)

Subjects diagnosed as being pregnant or in state of lactation
Subjects with serum creatinine greater than 1.2 or creatinine depuration in 24 hour urine, less than 60mL/min
Subjects who are receiving treatment with anti-depressants, anti-epileptics, and are taking vitamin B1 and B12 for treatment of neuropathic diabetes
Subjects who are being pharmacologically treated for epilepsy
Subjects diagnosed with rheumatic and hepatic disease and diagnosed with neuropathy for other causes

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
F0434Also: Gabapentin with thiamine and cobalaminF0434 will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2).	Drug	F0434
GabapentinAlso: Gababion, GavindoGabapentin will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2)	Drug	Gabapentin

Primary outcome

Mean Neuropathic Pain Score at Visit 3 (Week 1)
Time frame: Visit 3 (Week 1)
Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.
Mean Neuropathic Pain Score at Visit 4 (Week 2)
Time frame: Visit 4 (Week 2)
Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.
Mean Neuropathic Pain Score at Visit 5 (Week 3)
Time frame: Visit 5 (Week 3)
Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.
Mean Neuropathic Pain Score at Visit 6 (Week 4)
Time frame: Visit 6 (Week 4)
Neuropathic pain score included 10 pain descriptors (intensity, stinging, burning, dull pain, coldness, sensitivity, numbness, depth, superficial and unpleasant) quantified on a 0 (no symptoms) to 10 (worst symptoms imaginable). Questionnaire generated a score in each of the relevant dimensions and a total score of 0-100. Higher score indicated a greater intensity of pain.

1 secondary outcome

Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire
Time frame: Visit 2 (Baseline) to Visit 6 (Week 4)

Results and safety

Results posted to the registry on 27 Oct 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
Gabapentin	38	38
MF0434 + Gabapentin	37	37

Primary outcome: Mean Neuropathic Pain Score at Visit 3 (Week 1)

Time frame: Visit 3 (Week 1). Mean (Standard Deviation). Unit: Units on a Scale

Measure	Gabapentin n = 38	MF0434 + Gabapentin n = 37
Value	51.00 (17.39)	50.70 (16.67)

Population analysed: Per Protocol (PP) population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study Intention to treat (ITT) and PP populations were the same.

Primary outcome: Mean Neuropathic Pain Score at Visit 4 (Week 2)

Time frame: Visit 4 (Week 2). Mean (Standard Deviation). Unit: Units on a Scale

Measure	Gabapentin n = 38	MF0434 + Gabapentin n = 37
Value	41.24 (16.21)	36.94 (15.05)

Population analysed: PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.

Primary outcome: Mean Neuropathic Pain Score at Visit 5 (Week 3)

Time frame: Visit 5 (Week 3). Mean (Standard Deviation). Unit: Units on a Scale

Measure	Gabapentin n = 38	MF0434 + Gabapentin n = 37
Value	33.74 (19.54)	24.86 (13.52)

Population analysed: PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.

Primary outcome: Mean Neuropathic Pain Score at Visit 6 (Week 4)

Time frame: Visit 6 (Week 4). Mean (Standard Deviation). Unit: Units on a Scale

Measure	Gabapentin n = 38	MF0434 + Gabapentin n = 37
Value	22.08 (18.54)	17.29 (15.53)

Population analysed: PP population included all participants who were randomized and took at least 1 dose of study medication. In this clinical study ITT and PP populations were the same.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gabapentin	0 of 38 (0%)	22 of 38 (57.9%)	Not reported
MF0434 + Gabapentin	0 of 37 (0%)	23 of 37 (62.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Neuropathies

Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
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)
RecruitingObservational study
Efficacy and Safety of a Nitric Oxide Generating Dressing for Diabetic Foot Ulcers (ONWARD)
Diabetic Foot Ulcers (DFUs)
RecruitingPhase 2
Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
Diabetic Foot Ulcer
Not yet recruitingPhase 1
Placental Cells for Diabetic Foot Ulcers
Diabetic Foot Ulcer

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.

Medical Director study director

Merck S.A. de C.V., Mexico

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 F0434 and Gabapentin in people with Diabetic Neuropathies and Polyneuropathies, run by Merck KGaA, Darmstadt, Germany at 1 site in Mexico.

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 6 inclusion and 12 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 13 Feb 2014. 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 Mexico. 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?

Yes. Results are posted in the registry (first posted 27 Oct 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?

Mean Neuropathic Pain Score at Visit 3 (Week 1) (time frame: Visit 3 (Week 1)). The study lists 4 primary outcomes in all. 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 NCT01263132.

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 13 Feb 2014.