CTRI/2020/08/027186 [Registered on: 17/08/2020] Trial Registered Prospectively
Last Modified On:
03/01/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
To Compare the Efficacy and Safety of Pregabalin Extended Release Tablet to Placebo (inactive substance)
and Lyrica® (Pregabalin) Hard Capsule in Subjects with Peripheral Neuropathic Pain"
Scientific Title of Study
A Randomised, Multiple-dose, Multicentre, Three- Arm, Parallel Study to Compare the Efficacy and Safety of Pregabalin ER Tablet of Alvogen Malta (Out-Licensing) Ltd. to Placebo and Lyrica® (Pregabalin) Hard Capsule of Pfizer in Subjects with Peripheral Neuropathic Pain.
Protocol No.: CRL121953-Version: 02 -Date: 09 Oct 2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dharmesh Domadia
Designation
Associate Vice President - Global Clinical Operations
Affiliation
Cliantha Research Limited
Address
Cliantha Research Limited, Department Clinical Trials, Room no. 01,2nd floor, 6, Arista@Eight Corporate House, Near Satyam House,Behind Rajpath Club, Bodakdev, Ahmadabad-380054, Gujarat, India
Ahmadabad GUJARAT 380054 India
Phone
91-79-66219500
Fax
91-79-66219549
Email
ddomadia@cliantha.com
Details of Contact Person Scientific Query
Name
Dr Nil Desai
Designation
Assistant Manager Medical Services
Affiliation
Cliantha Research Limited
Address
Cliantha Research Limited, Department Clinical Trials, Room no. 01, 2nd floor, 6, Arista@Eight Corporate House, Near Satyam House,Behind Rajpath Club, Bodakdev, Ahmadabad-380054, Gujarat, India
Ahmadabad GUJARAT 380054 India
Phone
91-98-79732959
Fax
91-79-66219549
Email
nhdesai@cliantha.com
Details of Contact Person Public Query
Name
Mr Sumit Dodia
Designation
Project Manager – Clinical Trials
Affiliation
Cliantha Research Limited
Address
Cliantha Research Limited, Department Clinical Trials, Room no. 01,3nd floor, 6, Arista@Eight Corporate House, Near Satyam House,
Behind Rajpath Club, Bodakdev, Ahmadabad
Ahmadabad GUJARAT 380054 India
Phone
91-98-25538366
Fax
91-79-66219549
Email
sdodia@cliantha.com
Source of Monetary or Material Support
Alvogen Malta (Out-Licensing) Ltd, Malta Life Sciences Park, Building 1 Level 4, Sir Temi Zammit Buildings, San Gwann Industrial Estate, San Gwann SGN 3000 Malta
Primary Sponsor
Name
Alvogen Malta OutLicensing Ltd
Address
Malta Life Sciences Park, Building 1 Level 4, Sir Temi Zammit Buildings, San Gwann Industrial Estate, San Gwann SGN 3000 Malta
Unique Hospital- Multispeciality and Research Institute
Department of clinical research, Room no. NA, Opp. Kiran Motor, Canal Road, Civil Hospital Char Rasta - Sosyo Circle Lane, Off ring road-395002
Surat, Gujarat
Surat GUJARAT
Pregabalin ER Tablet of Alvogen Malta (Out-Licensing) Ltd
Orally within 1 hour after completion of Meal : Single Dose : minimum 165 mg to increase gradually maximum 660 mg in first 4 week (with dose titration up or down by 82.5 mg/day or 165 mg/day); after that will be continued in a fixed manner till Week 13 & following week 14 is Dose Tapering.
Comparator Agent
Pregabalin ER Tablet of Alvogen Malta (Out-Licensing) Ltd.
Lyrica® (Pregabalin) Hard Capsule of Pfizer
Orally in two or three divided doses with minimum 150 mg/day to increase gradually 600 mg/day in first 4 weeks (with dose titration up or down by 75 mg/day or 150 mg/day); after that will be continued in a fixed manner till week 13 & following week 14 is dose Tapering.
1.Male and/or non-pregnant or non-lactating female subject ≥ 18 years of age or above. Subject with any one of the following conditions during first visit:
2.For PHN (Post herpatic neuralgia): Subject must have pain for more than 3 months after healing of the herpes zoster skin rash.
And/or
3.For DPN (diabetic peripheral neuropathy): Subject should have a history of diabetes mellitus (Type I or Type II) and painful, sensorimotor polyneuropathy for ≥ 6 months.
4.At screening visit and baseline visit, subject must have a score of ≥ 4 on the pain NRS scale (1-week recall period).
5.At baseline visit, at least 4 pain diary entries must be completed within the last 7 days and the average pain score must be ≥ 4.
6.Subject with a creatinine clearance of at least 60 mL/min (estimated from serum creatinine).
7.Subject who agrees not to use any other approved or experimental pharmacological treatments for neuropathic pain at any time during the study.
8.Subject able to understand the investigational nature of this study and give written informed consent prior to study entry.
9.Able to comply with study requirements in the opinion of investigator.
10.Female subject of childbearing potential must have a confirmed negative pregnancy test prior to enrolment.
11.Male or female of childbearing potential must be willing to use adequate methods of contraception throughout the study.
12.Subject with a history of depression that is in remission, with or without antidepressant treatment, can participate, unless a stable antidepressant regimen includes a prohibited medication.
Note: Antidepressant medication may not be changed or discontinued to meet entry criteria and must be stable for at least three months prior to the start of the baseline period. Condition of depression will be evaluated by investigator in consultation with psychiatrist.
ExclusionCriteria
Details
1.Female who are breastfeeding, pregnant or planning to become pregnant.
2.History of hypersensitivity or allergy to pregabalin, or other α2δ ligands (e.g. gabapentin) or any of the study medication ingredients.
3.Skin conditions in the affected dermatome that could alter sensation.
4.Meets criteria as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) for a major depressive episode or for active CNS disorders within a year prior to screening visit, including dementia, psychosis, seizure, post-traumatic stress disorder or bipolar disorder.
5.Nerve block or acupuncture or special procedures (e.g. TENS) for the relief of pain performed 4 weeks prior to the baseline visit and throughout the duration of the study.
6.Subject with known intolerance or refractory to pregabalin.
7.Use of prohibited medications in the absence of appropriate washout periods.
8.Subject with suicidal ideation (score of 4 or 5 on the Columbia Suicide Severity Rating Scale [C-SSRS]) within the past 2 months or any suicidal behaviour occurring in the past year.
9.Pregabalin use in the last 30 days prior to screening visit. Subject taking pregabalin should undergo wash out of pregabalin for at least 30 days prior to the screening visit.
10.Subject with a history of life-threatening neoplasms within 5 years prior to screening visit, other than carcinoma in situ of the cervix or basal cell carcinoma of the skin.
11.Subject with difficulty in swallowing or unable to tolerate oral medication.
12.Subject with active GI disease including any GI surgery that in the opinion of the investigator would interfere with the absorption of study medication.
13.Subject who has taken neurolytic or neurosurgical therapy for neuropathic pain.
14.Subject suffering with other types of neuropathic pain.
15.Subject with history of chronic obstructive pulmonary disease (COPD), asthma or respiratory depression disorder.
16.Presence of severe pain associated with conditions other than study indication that could confound the assessment or self-evaluation of neuropathic pain, examples, amputation other than toes, psychiatric disorders, non-diabetic neurologic disorders, and skin conditions affecting sensation in painful limbs.
17.Subject with a history of angle-closure glaucoma, angioedema, urinary retention, thyroid disorder, uncontrolled hypertension (systolic BP ≥ 150 mmHg/diastolic BP ≥ 100 mmHg) or clinically significant ECG abnormality or the participant has any other abnormal laboratory value of clinical significance for this study.
18.Subject with HbA1c ≥ 10 % at screening visit.
19.Subject with known alcohol or other substance abuse within the last one year.
20.Subject associated with profession of driving or operating heavy machineries.
21.Subject participated in any other clinical study using investigational drug in past 30 days before the date of screening visit.
22.Institutionalised subject.
23.Live in the same household as currently enrolled subject.
24.Other severe acute or chronic medical or psychiatric conditions or laboratory abnormalities that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into the trial.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Investigator Blinded
Primary Outcome
Outcome
TimePoints
Change in mean weekly pain score from baseline to end of treatment.
15 weeks
Secondary Outcome
Outcome
TimePoints
1.Proportion of subjects reporting ≥ 30% reduction in weekly mean pain score.
2.Change in mean weekly sleep interference score from baseline to end of treatment.
3.Comparison of subject rating of change in overall status as measured by Patient Global Impression of Change (PGIC) at end of treatment.
15 weeks
Target Sample Size
Total Sample Size="453" Sample Size from India="453" Final Enrollment numbers achieved (Total)= "453" Final Enrollment numbers achieved (India)="453"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A Phase Study, to compare the Peripheral Neuropathic Pain effect of Pregabalin ER Tablet of Alvogen Malta (Out-Licensing) Ltd. to Placebo and Lyrica® (Pregabalin) Hard Capsule of Pfizer in Diabetic Neuropathic Pain & Post Herpatic Neuralgia Subjects& To evaluate the safety and tolerability of investigational products