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3D1002 in Combination With Oxycodone Hydrochloride Sustained-release Tablets in Patients With Moderate to Severe Cancer Pain

ConditionCancer Pain
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
Sponsor3D Medicines

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject must sign the informed consent in person prior to beginning any screening procedure.

Age ≥18, both male and female.

Subjects with a malignant tumor confirmed by histopathology or cytology.

Weight ≥40 kg at screening period.

Disqualifiers

Known allergy to any of the active ingredients or excipients of the study drug, or have a history of allergy to other opioids or non-steroidal anti-inflammatory drugs (NSAIDs) and their related ingredients.

Have a persistent pain resulted from other medical conditions or unknown causes.

Subjects presenting with emergency symptoms such as intestinal obstruction/perforation, spinal cord compression, epidural metastasis, or fracture.

Subjects with known active/symptomatic central nervous system metastasis and/or cancerous meningitis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 3D1002 (50 mg)(Phase IIa)

    Drug

    1 tablet of 3D1002 per oral dose

  • 3D1002 (100 mg)(Phase IIa)

    Drug

    2 tablets of 3D1002 per oral dose

  • 3D1002 (150 mg)(Phase IIa)

    Drug

    3 tablets of 3D1002 per oral dose

  • 3D1002 monotherapy (Phase IIb)

    Drug

    3D1002 is administered at recommended dose with mimic OxyContin tablets.

  • OxyContin monotherapy (Phase IIb)

    Drug

    OxyContin is administered at an initial dose of 10 mg per dose with mimic 3D1002 tablets.

  • 3D1002 + OxyContin (Phase IIb)

    Drug

    3D1002 is administered at recommended dose, and OxyContin is administered at an initial dose of 10 mg per dose.

Treatment groups

177 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: 3D1002 50 mg group (Phase IIa)Experimental treatment 1 intervention
Group B: 3D1002 100 mg group (Phase IIa)Experimental treatment 1 intervention
Group C: 3D1002 150 mg group (Phase IIa)Experimental treatment 1 intervention
Group D: 3D1002 monotherapy group (Phase IIb)Experimental treatment 1 intervention
Group E: OxyContin monotherapy group (Phase IIb)Experimental treatment 1 intervention
Group F: 3D1002 + OxyContin group (Phase IIb)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Time to achieve effective pain control

Time frame
1 to 14 days after receiving study treatment
3

Time-specific pain intensity difference（PID）

Time frame
1 to 14 days after receiving study treatment
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

3D Medicines

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: