Health Condition 1: M545- Low back pain
Conditions
Interventions
Intervention1: 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
Control Inte
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Mean Numeric Pain Rating Scale (NPRS) levelsTimepoint: Baseline to end of week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage Change in Mean Numeric Pain Rating Scale (NPRS) levelsTimepoint: Baseline to end of week 4 and week 8;Change in Mean Numeric Pain Rating Scale (NPRS) levelsTimepoint: Baseline to week 4;Change in Mean Visual Analog Scale (VAS)Timepoint: Baseline to week 4 and week 8;Change in Mean Roland-Morris Disability Questionnaire (RMDQ)Timepoint: Baseline to week 4 and week 8;Consumption of rescue medication (total dose of paracetamol tablets consumed)Timepoint: Baseline to week 4 and week 8;Patient Global Impression of Improvement (PGI-I)Timepoint: At week 4 and week 8;Clinical Global Impression of Improvement (CGI-I)Timepoint: At week 4 and week 8;Treatment emergent clinical & laboratory adverse events (TEAEs)Timepoint: End of week 4 and week 8 | — |
Countries
India
Contacts
Public ContactMohan Reddy Bandi
Hetero Labs Limited
Outcome results
None listed