CTRI

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CTRI Number

CTRI/2025/11/097453 [Registered on: 14/11/2025] Trial Registered Prospectively

Last Modified On:

16/04/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Comparative Effect of Pregabalin ER 82.5mg and Polmacoxib 2mg in adult participants with Chronic Lower Back Pain.

Scientific Title of Study

A Prospective, Multi-Center, Double blind, Comparative, Active-Controlled, Parallel Group, Randomized Study to Evaluate the Efficacy and Safety of Fixed Dose Combination (FDC) of Pregabalin ER 82.5mg and Polmacoxib 2mg compared to Pregabalin 75 mg and Etoricoxib 60mg in Indian Adult Patients with Chronic Lower Back Pain.

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
HCR/III/POLPRELBP/02/2023, Version 2.0; Date 06.12.2024	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Shubhadeep Sinha MD
Designation	Senior Vice President and Head
Affiliation	Hetero Labs Limited
Address	7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad Hyderabad TELANGANA 500018 India
Phone	04023704923
Fax
Email	sd.sinha@heterodrugs.com

Details of Contact Person
Scientific Query

Name	Dr Sreenivasa Chary S
Designation	Senior General Manager
Affiliation	Hetero Labs Limited
Address	7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad Hyderabad TELANGANA 500018 India
Phone	04023704923
Fax
Email	Sreenivasa.Chary@hetero.com

Details of Contact Person
Public Query

Name	Mohan Reddy Bandi
Designation	General Manager
Affiliation	Hetero Labs Limited
Address	7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad Hyderabad TELANGANA 500018 India
Phone	04023704923
Fax
Email	B.MohanReddy@heterodrugs.com

Source of Monetary or Material Support

Hetero Labs Limited, 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad

Primary Sponsor

Name	Hetero Labs Limited
Address	7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar Hyderabad
Type of Sponsor	Pharmaceutical industry-Global

Details of Secondary Sponsor

Name	Address
NA	NA

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 10
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Bhaskar Konatham	ACSR Government Medical College and Hospital	Department of Orthopedics, Ground floor, Room No. 06 Nellore ANDHRA PRADESH	9866409222 bhaskar.svmc@gmail.com
Dr Ashok Sampagar	Belagavi Institute of Medical Sciences	Department of Orthopaedic, OPD room no. 69, Ground Floor Belgaum KARNATAKA	9886736079 ashok.samp@gmail.com
Dr Bachu Srinivas	Gandhi Hospital	Department of Orthopaedics, In-Patient block, Ground Floor, Room No 1 Hyderabad TELANGANA	8639271151 Srinibachu@gmail.com
Dr Kishore Babu Sattaru	Government Medical College & Govt General Hospital	Department of Orthopaedics, Room No 3, Ground Floor Srikakulam ANDHRA PRADESH	9885422945 drskishorebabu@yahoo.com
Dr Ujjwal Kanti Debnath	Health Point Hospital	Indoriv Clinical Research room, Ground floor, 700025, India Kolkata WEST BENGAL	9051588823 ujjwalkd@yahoo.com
Dr Brijesh Jerambhai Patel	Hi-Tech Multispeciality Hospital	Department of Orthopedics Ground Floor, Room No 01 Gandhinagar GUJARAT	9825686088 hitechhospital.cr@gmail.com
Dr Rakesh Verma	Jawahar Lal Nehru Medical College	Department of Orthopedics Ground Floor, Room No1 Ajmer RAJASTHAN	9460195960 rakeshverma.jln@outlook.com
Dr Vikalp Vashishtha	Maharaja Agrasen Superspeciality Hospital	Department of Orthopedics Room No 101, Ground Floor Jaipur RAJASTHAN	9829113330 drvikalpvashishth@gmail.com
Dr Arvind Kumar Kankane	MLB Medical College	Department of Neurology Ground Floor, Room No 9 Jhansi UTTAR PRADESH	9838072655 drarvind_neuro@rediffmail.com
Dr Ramachandra Kamath K	Omega Hospital	OPD, Room No. B11, Basement Dakshina Kannada KARNATAKA	9448452593 drkrk.epsilon@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 10
Name of Committee	Approval Status
Ethics committee, MLB Medical college	Approved
HEALTH POINT ETHICS COMMITTEE	Approved
IEC Maharaja Agrasen Hospital	Approved
Institutional Ethics Committe, Gandhi Hospital	Approved
Institutional Ethics Committee, ACSR Government Medical College and Hospital	Approved
Institutional Ethics Committee, Belagavi Institute of Medical Sciences	Approved
Institutional Ethics Committee, Government General Hospital, Srikakulam	Approved
Institutional Ethics Committee, JLN Medical College	Approved
Omega Ethical Committee Omega Hospitals (P) Ltd	Approved
Rhythm Hospital ethics committee	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: M545\|\|Low back pain,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Comparator	Reference Pregabalin 75 mg and Etoricoxib 60mg dose will be administer orally One Tablet once a day with or without food for 08 weeks
Intervention	Intervention	Fixed Dose Combination (FDC) of Pregabalin ER 82.5mg and Polmacoxib 2mg dose will be administer orally One Tablet once a day with or without food for 08 weeks

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Adult male or female patients aged of 18-65 years 2. Patients willing to give written, signed, and dated informed consent to participate in the study. 3. Patients with chronic low back pain (symptoms duration: greater than or equal to 3 months) and at least one of the following features on the side corresponding to leg pain: a. Sharp and shooting pain below the knee b. Pain evoked by straight leg raising to 60 degrees or less c. Decreased or absent ankle reflex d. Weakness of muscles below the knee e. Sensory loss in L5/S1 distribution 4. Patients who have pain score of at least 4 on the Numeric Pain Rating Scale (11-point).

ExclusionCriteria

Details

1. Patients with any contraindication, hypersensitivity or intolerance to either pregabalin or polmacoxib therapies or with history of hypersensitivity reactions to drugs of similar chemical classes or to any of its excipients.
2. History of Hepatitis B, Hepatitis C or HIV infection.
3. Use of any medications for ongoing chronic symptoms, or psychiatric disorders that could significantly diminish the cognitive ability or cause behavioral changes that would prevent the subject from complying with study procedures.
4. Patients on anticonvulsants, antidepressants (e.g., tricyclic, tetracyclic, atypical), aspirin at doses more than 81 mg/day, benzodiazepines, opioids, herbal medications, mexiletine HCl.
5. Patients with HbAlc greater than 8% at screening.
6. Patient received treatment with an investigational device or compound.
within 6 months prior of the screening.
7. Patients with known alcohol or other substance abuse within last one year as per DSM-5 criteria.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Centralized

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Change in Mean Numeric Pain Rating Scale (NPRS) levels	Baseline to end of week 8

Secondary Outcome

Outcome	TimePoints
Percentage Change in Mean Numeric Pain Rating Scale (NPRS) levels	Baseline to end of week 4 and week 8
Change in Mean Numeric Pain Rating Scale (NPRS) levels	Baseline to week 4
Change in Mean Visual Analog Scale (VAS)	Baseline to week 4 and week 8
Change in Mean Roland-Morris Disability Questionnaire (RMDQ)	Baseline to week 4 and week 8
Consumption of rescue medication (total dose of paracetamol tablets consumed)	Baseline to week 4 and week 8
Patient Global Impression of Improvement (PGI-I)	At week 4 and week 8
Clinical Global Impression of Improvement (CGI-I)	At week 4 and week 8
Treatment emergent clinical & laboratory adverse events (TEAEs)	End of week 4 and week 8

Target Sample Size

Total Sample Size="228"
Sample Size from India="228"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3

Date of First Enrollment (India)

24/11/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="6"
Days="0"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This is a Prospective, Multi-Center, Double blind, Comparative, Active-Controlled, Parallel Group, Randomized Study to Evaluate the Efficacy and Safety of Fixed Dose Combination (FDC) of Pregabalin ER 82.5mg and Polmacoxib 2mg compared to Pregabalin 75 mg and Etoricoxib 60mg in Indian Adult participants with Chronic Lower Back Pain. Adult male or female participants aged of 18-65 years with chronic low back pain (symptoms duration greater than or equal to 3 months) will be enrolled into the study. The study will consist of up to14-days screening period, 8 weeks treatment period. Approximately 228 patients will be randomized into either Test arm or Comparator arm. Participants will receive either Hetero Fixed Dose Combination (FDC) of Pregabalin ER 82.5mg and Polmacoxib 2mg or Reference Pregabalin 75 mg and Etoricoxib 60mg dose will be administer orally One Tablet once a day with or without food for 08 weeks.