A Study of Gabapentin and Nortriptyline in Comparison with Gabapentin in Patients with Nerve Pain
Scientific Title of Study
A Double Blind, Double-Dummy, Randomized, Prospective, Two Arm, Parallel, Multicenter, Phase IV Clinical Trial to Evaluate Efficacy and Safety of Gabapin NT (Fixed-Dose Combination of Gabapentin and Nortriptyline) in Comparison with Gabapentin in Patients with Neuropathic Pain
Secondary IDs if Any
Secondary ID
Registry
0555-17, Version 1.0 Dated 31 July 2017
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Mr Prashant Modi
Address
Lambda House, Plot no. 38, Survey No. 388 Near Silver Oak Club,
S. G. Highway, Gota Ahmadabad GUJARAT 382481 India
Phone
07940202375
Fax
07940202021
Email
prashantmodi@lambda-cro.com
Details Contact Person Scientific Query
Name
Dr Ravi Alamchandani
Address
Lambda House, Plot no. 38, Survey No. 388 Near Silver Oak Club,
S. G. Highway, Gota Ahmadabad GUJARAT 382481 India
Fixed Dose Combination (FDC) of gabapentin 400 mg and nortriptyline 10 mg of Intas Pharmaceuticals Limited, India
Dose: One Tablet along with One Dummy Capsule;
Frequency: Day 1-3 (Once Daily, Day 4-6(Twice Daily),
Day 7-35(Thrice a Day); Mode of Administration:Oral; Duration of treatment: 35 days
Comparator Agent
Gabapentin 400 mg Capsule of Intas Pharmaceuticals Limited, India
Dose: One capsule along with Dummy Tablet; Frequency: Day 1-3 (Once Daily, Day 4-6(Twice Daily), Day 7-35(Thrice a Day); Mode of Administration:Oral; Duration of treatment: 35 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1 Patients of either gender between 18 and 65 years (both inclusive).
2 Diagnosis of chronic neuropathic pain by investigator before at least 3 months of screening
3 Patient having daily pain score greater than or equal to 4 on Numeric Rating Scale (NRS) of 0-10 at the time of screening and on day of enrolment (after washout period).
4 Score of 12 or more on Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score
5 Patients have at least two of the following non-specific symptoms: allodynia (pain from a non-noxious stimulus, e.g. touch), burning
pain, shooting pain, or hyperalgesia (increased sensitivity to a noxious stimulus) at the time of screening.
6 Provides written informed consent in accordance with applicable regulatory requirements
ExclusionCriteria
Details
1 Any major organ system disease, cardiovascular autonomic neuropathy, sedation or ataxia due to concomitant drugs or other
cause.
2 Urinary symptoms attributable to benign prostatic hypertrophy in male participants.
3 Vitamin B12 level below 180 ng/L or uncontrolled hypothyroidism in spite of adequate treatment
4 Patients with any orthopaedic alteration of any extremity
5 Patients with peripheral artery disease
6 Patients taking more than two neuropathic pain medicines
7 Presence of a seizure disorder.
8 Patients who are receiving treatment with anti-depressants, antiepileptics
9 Patients with uncontrolled Angle-closure glaucoma.
10 Haemoglobin A1c concentration more than 13% at screening
11 Ongoing administration of Monoamine Oxidase (MAO) inhibitors and/or a serious psychiatric disorder as diagnosed by a psychiatrist.
12 A coexisting disorder causing pain as severe as the neuropathic pain.
13 Women of childbearing potential not receiving an effective form of contraception.
14 Pregnant woman or lactating mother.
15 Known hypersensitivity to gabapentin, nortriptyline or any of its ingredients.
16 Ongoing administration of anticonvulsants which induce cytochrome P450 enzymes (e.g., carbamazepine, oxcarbazepine).
17 Patient who require treatment with a drug that prolongs QT interval.
18 Creatinine clearance ≤ 60 ml/min or known case of renal impairment.
19 Clinically significant laboratory abnormalities at the time of screening.
20 Abuse or dependency of alcohol, narcotics, opioids or any other addictive substances (other than Benzodiazepine).
21 Patients participated in any type of clinical study within the last 30 days of the screening date.
22 Unsuitability for enrollment otherwise as decided by investigator.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Change in mean pain intensity from baseline to end of treatment by
Numeric Rating scale (NRS)
From Baseline to end of treatment
Secondary Outcome
Outcome
TimePoints
1. Change From Baseline to end of treatment in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Scale Score
2. Change in Global Impression of Patient Change (GIPC) Scale from baseline to end of treatment
3. Change in Clinical Global Impression of Change (CGIC) Scale from baseline to end of treatment
4. Safety evaluation by comparison of adverse events and serious adverse events in each arm.
From Baseline to end of treatment
Target Sample Size
Total Sample Size="332" Sample Size from India="332"
Phase of Trial
Phase 4
Date of First Enrollment (India)
21/02/2018
Date of First Enrollment (Global)
No Date Specified
Estimated Duration of Trial
Years="1" Months="4" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
Not Yet
Brief Summary
Neuropathic pain—defined as pain resulting from lesions or diseases of the sensory transmission pathways in the peripheral or central nervous system—is characterized by pain and sensory abnormalities in body areas that have lost their normal sensory innervation. Approach to treat neuropathic pain should be to improve physical functioning, to reduce psychological consequences of pain and to improve one’s overall quality of life. Identifying the nature of a patient’s pain actually provides a guideline towards its treatment. Neuropathic pain is challenging to manage, and many patients have pain that is refractory to existing treatments. Hence, in clinical practice, two or more medications are often used in combination to possibly achieve either an additive beneficial effect or a reduction in the adverse effects associated with the use of a single medication. This is a double blind, double-dummy, randomized, prospective, two arm, parallel, multicenter, phase IV clinical trial. Patients who were diagnosed with neuropathic pain having a Pain Intensity by Numeric Rating Scale score greater than or equal to 4 on screening and at baseline will be recruited. There will be two weeks of screening period during which potentially eligible patients will undergo detailed clinical examination, disease assessment and laboratory investigations. Patient will discontinue the ongoing treatment, if any for neuropathic pain, during screening period (washout period of minimum 7 days; in case of benzodiazepines (BZDs) this will be of 12-14 days). Patients fulfilling all the eligibility criteria following the screening procedures will be included in this study to receive either test drug and dummy of reference drug or reference drug and dummy of test drug for a total duration of 35 days. There will be a total 06 visits for each patient. Total 332 patients (166 patients per arm) will be enrolled in the study. Safety will be assessed throughout by AE reporting, laboratory testing (hematology, blood/serum biochemistry, and urinalysis), recording of vital signs during every visit.
