This study aims to evaluate the safety and efficacy of 3D1002 alone or in combination with oxycodone hydrochloride sustained-release tablets (OxyContin) for the management of moderate or severe cancer pain.
The investigational product in this study, 3D1002, is a selective antagonist of prostaglandin E2 receptor subtype 4 (EP4). The study is composed of two stages. Phase IIa stage is to assess the safety and efficacy of 3D1002 administered at doses of 50, 100 or 150 mg every 12 hour (q12h) for patients with moderate to severe cancer pain, and to determine the optimal recommended dose for further studies. Phase IIb stage is to evaluate the difference in the efficacy and safety of 3D1002 combined with OxyContin and OxyContin alone in treatment of patients with moderate to severe cancer pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
177
1 tablet of 3D1002 per oral dose
2 tablets of 3D1002 per oral dose
3 tablets of 3D1002 per oral dose
Sum of pain intensity difference in the Numeric Rating Scale (NRS) within 14 days after the first study drug treatment (SPID14)
①Average pain intensity is calculated daily for the past 24 hours using the NRS (0 = No pain, 10 = Worst pain imaginable). ②PID (pain intensity difference): Baseline pain intensity score (for the day prior to the day of randomization) minus pain intensity score at each given day.③SPID: the sum of the pain intensity difference generated daily from day 1 to the designated day.
Time frame: 1 to 14 days after receiving study treatment
Proportion of subjects who achieve effective pain control
Effective pain control: mean NRS score within 0-3 points and episode of breakthrough pain ≤ 2 times in 24 hours
Time frame: 1 to 14 days after receiving study treatment
Time to achieve effective pain control
Time frame: 1 to 14 days after receiving study treatment
Time-specific pain intensity difference(PID)
Time frame: 1 to 14 days after receiving study treatment
Sum of pain intensity difference (SPID) in the NRS within 3,5 and 7 days post-treatment
Time frame: from day 1 to 3, 5 and 7 after receiving study treatment, respectively
Time-specific subject self-rated pain relief based on Brief Pain Inventory Short Form (BPI-SF) Questionnaire Item 8
The pain relief is assessed daily for the past 24 hours based on the percentage of relief from baseline, ranging from 0 (no relief) to 100% (complete relief).
Time frame: 1 to 14 days after receiving study treatment
Sum of subject self-rated pain relief based on BPI-SF Questionnaire Item 8 within 3,5,7 and 14 days post-treatment
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3D1002 is administered at recommended dose with mimic OxyContin tablets.
OxyContin is administered at an initial dose of 10 mg per dose with mimic 3D1002 tablets.
3D1002 is administered at recommended dose, and OxyContin is administered at an initial dose of 10 mg per dose.
Time frame: from day 1 to 3, 5, 7 and 14 after receiving study treatment, respectively
Proportion of subjects with pain response over 7 and 14 days after treatment
Pain response: at least 30% and 50% decrease in pain intensity NRS score from baseline.
Time frame: 1 to 14 days after receiving study treatment
Time to pain response
Time frame: 1 to 14 days after receiving study treatment
The number of breakthrough pain episodes and rescue dose of immediate-release oxycodone over 7 and 14 days after treatment;
Time frame: 1 to 14 days after receiving study treatment
Time-specific oxycodone dose, including immediate-release oxycodone capsules and sustained-release oxycodone tablets (the latter is only applicable for phaseⅡb)
Time frame: 1 to 14 days after receiving study treatment
Total dose of oxycodone over 3, 7, and 14 days post-treatment
Time frame: 1 to 14 days after receiving study treatment
Patient's global impression of change (PGI-C) over 7 and 14 days after treatment (for phase IIb only)
PGI-C is a participant rated instrument to measure participant's change in overall status of general condition including pain on a 7-point scale, with 1 being "very much improved" and 7 being "very much worse".
Time frame: 1 to 14 days after receiving study treatment
Frequency and severity of adverse events during treatment
Time frame: 1 to 14 days after receiving study treatment