Trial design
 
 
 

The efficacy and safety of Taphalgin in patients with cancer pain.

A Phase 3 open-label, comparative, randomized clinical trial to study the efficacy and safety of Taphalgin in adult cancer patients with pain syndrome.

Eligible patients aged 18 to 80 years were randomized into two groups in a 2:1 ratio using an electronic CRF (eCRF), according to the randomization plan.

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  • Patients in Group 1 received Taphalgin, solution for subcutaneous injection, in an individually selected dose throughout the study (for 84 days)
    • 78 male (65.0 %) and 42 female patients (35.0 %),
    • the age of patients (Mean±SD): 57.27±9.04 years (32 to 76 years),
    • body mass index (Mean±SD): 25.58±4.65 kg/m² (18.2 to 40.8 kg/m²).

 

  • Patients in Group 2 received oral morphine for 28 days (Period 1) from the end of the dose selection phase. Then (Period 2), the patients were switched to Taphalgin, solution for subcutaneous injection, in an individually selected dose, which they received until completion of the clinical trial
    • 38 male (64.41 %) and 21 female (35.59 %),
    • the age of patients (Mean±SD): 58.52±8.71 years (38 to 70 years),
    • body mass index (Mean±SD): 25.76±4.77 kg/m² (18.4 to 38.0 kg/m²).

No significant intergroup differences in terms of the patients' demographic and anthropometric data and sex distribution.

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