Trial Outcomes & Findings for Neuropathic Pain Management (NCT NCT01263132)

Last Updated: 2014-02-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

104 participants

Primary outcome timeframe

Visit 3 (Week 1)

Results posted on

2014-02-13

Participant Flow

A total of 104 participants were recruited for the study, out of which 29 participants were screen failures which were not randomized and did not receive study treatment.

Participant milestones

Participant milestones
Measure	Gabapentin Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.	MF0434 + Gabapentin MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
Overall Study STARTED	38	37
Overall Study COMPLETED	38	37
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neuropathic Pain Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gabapentin n=38 Participants Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.	MF0434 + Gabapentin n=37 Participants MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.	Total n=75 Participants Total of all reporting groups
Age, Continuous	52.6 years STANDARD_DEVIATION 9.7 • n=5 Participants	51.1 years STANDARD_DEVIATION 9.9 • n=7 Participants	51.9 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: Visit 3 (Week 1)

Population: 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.

Outcome measures

Outcome measures
Measure	Gabapentin n=38 Participants Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.	MF0434 + Gabapentin n=37 Participants MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
Mean Neuropathic Pain Score at Visit 3 (Week 1)	51.00 Units on a Scale Standard Deviation 17.39	50.70 Units on a Scale Standard Deviation 16.67

PRIMARY outcome

Timeframe: Visit 4 (Week 2)

Population: 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.

Outcome measures

Outcome measures
Measure	Gabapentin n=38 Participants Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.	MF0434 + Gabapentin n=37 Participants MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
Mean Neuropathic Pain Score at Visit 4 (Week 2)	41.24 Units on a Scale Standard Deviation 16.21	36.94 Units on a Scale Standard Deviation 15.05

PRIMARY outcome

Timeframe: Visit 5 (Week 3)

Population: 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.

Outcome measures

Outcome measures
Measure	Gabapentin n=38 Participants Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.	MF0434 + Gabapentin n=37 Participants MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
Mean Neuropathic Pain Score at Visit 5 (Week 3)	33.74 Units on a Scale Standard Deviation 19.54	24.86 Units on a Scale Standard Deviation 13.52

PRIMARY outcome

Timeframe: Visit 6 (Week 4)

Population: 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.

Outcome measures

Outcome measures
Measure	Gabapentin n=38 Participants Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.	MF0434 + Gabapentin n=37 Participants MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
Mean Neuropathic Pain Score at Visit 6 (Week 4)	22.08 Units on a Scale Standard Deviation 18.54	17.29 Units on a Scale Standard Deviation 15.53

SECONDARY outcome

Timeframe: Visit 2 (Baseline) to Visit 6 (Week 4)

Population: 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. Two participants in the MF0434 + Gabapentin group had missing values and hence are not included.

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.

Outcome measures

Outcome measures
Measure	Gabapentin n=38 Participants Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.	MF0434 + Gabapentin n=35 Participants MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire Baseline (Visit 2): General SF-36 QoL Index	53.044 Units on a Scale Standard Deviation 22.409	56.507 Units on a Scale Standard Deviation 19.523
Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire Week 1 (Visit 3): General SF-36 QoL Index	65.779 Units on a Scale Standard Deviation 20.882	65.610 Units on a Scale Standard Deviation 18.599
Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire Week 2 (Visit 4): General SF-36 QoL Index	69.531 Units on a Scale Standard Deviation 18.987	74.370 Units on a Scale Standard Deviation 15.595
Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire Week 3 (Visit 5): General SF-36 QoL Index	73.058 Units on a Scale Standard Deviation 18.102	78.075 Units on a Scale Standard Deviation 15.819
Quality of Life Survey Assessed Using Short Form 36 (SF-36) Questionnaire Week 4 (Visit 6): General SF-36 QoL Index	78.869 Units on a Scale Standard Deviation 17.010	82.331 Units on a Scale Standard Deviation 15.793

Adverse Events

Gabapentin

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

MF0434 + Gabapentin

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Gabapentin n=38 participants at risk Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.	MF0434 + Gabapentin n=37 participants at risk MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
Nervous system disorders Drowsiness	34.2% 13/38 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	16.2% 6/37 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Nervous system disorders Dizziness	31.6% 12/38 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	54.1% 20/37 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Nervous system disorders Headache	7.9% 3/38 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	10.8% 4/37 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Metabolism and nutrition disorders Hypoglycemia	5.3% 2/38 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	2.7% 1/37 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
General disorders Lower Limb Edema	2.6% 1/38 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	5.4% 2/37 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Infections and infestations Viral Rhinopharyngitis	2.6% 1/38 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	0.00% 0/37 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Gastrointestinal disorders Colitis	2.6% 1/38 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	0.00% 0/37 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Gastrointestinal disorders Gastroenteritis	2.6% 1/38 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	0.00% 0/37 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Infections and infestations Acute Otitis Media	0.00% 0/38 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	2.7% 1/37 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
General disorders Edema	0.00% 0/38 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	2.7% 1/37 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Skin and subcutaneous tissue disorders Widespread Urticaria	0.00% 0/38 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	2.7% 1/37 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Vascular disorders Hypertension	0.00% 0/38 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	2.7% 1/37 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.
Gastrointestinal disorders Pyrosis	0.00% 0/38 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.	2.7% 1/37 • Up to 4 weeks An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered.

Additional Information

Medical Responsible

Merck S.A. de C.V., Mexico, an affiliate of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place