Clinical trial · Interventional
A Clinical Trial to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain
A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): due to strategic reasons
Summary
Brief summary (as posted)
The primary objective of this study is to evaluate the efficacy of SSR411298 200 mg daily compared to placebo as adjunctive treatment for persistent cancer pain based on Numeric Rating Scale (NRS). Secondary Objectives are: * To evaluate the effect of SSR411298 200 mg daily on pain, breakthrough pain frequency, background therapy utilization, mood, patient satisfaction of pain relief, nausea, constipation, healthcare utilization and quality of life; * To evaluate the tolerability and safety of SSR411298 as adjunctive treatment for persistent cancer pain; * To characterize patient disease, in terms of cancer, cancer treatment, cancer pain and cancer pain treatment; * To evaluate the pharmacokinetic (PK) exposure of SSR411298 as adjunctive treatment for persistent cancer pain; * To assess endocannabinoid plasma concentrations.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breakthrough Cancer Pain | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo (for SSR411298) | Drug | — | UNRESOLVED |
| SSR411298 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SSR411298 200 mg
- description
- SSR411298 200 mg, one tablet once daily for 4 weeks
- interventionNames
- Drug: SSR411298
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo (for SSR411298), one tablet once daily for 4 weeks
- interventionNames
- Drug: Placebo (for SSR411298)
Primary outcomes (1)
- measure
- Change from baseline in average Numeric Rating Scale (NRS) pain intensity score
- timeFrame
- 5 weeks (from D-7 (seven days before randomization) up to D28)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: Patient with moderate or severe, persistent cancer pain who is receiving the World Health Organization (WHO) Step 2 or 3 cancer pain treatment: * Pain generator (source of pain) must be primarily due to underlying cancer or cancer treatment; * Pain generator (source of pain) must be classified as either primarily nociceptive or primarily neuropathic; * Pain severity must be moderate or severe with an average NRS score ≥4 during the screening week. Exclusion criteria: * Instability of pain during the screening week; * Use of prohibited adjuvant pain treatment in the week prior to study entry or plan to use these medications during the study; * Current use of medication containing tetrahydrocannabinol (THC); * Chemotherapy within 4 weeks before study entry or chemotherapy planned during the study (a stable regiment of hormonal therapy is permitted); * Radiotherapy within 4 weeks before study entry or radiotherapy planned during the study (hemostatic palliative radiotherapy is permitted); * Cancer related surgery within 4 weeks before study entry or cancer-related surgery planned during the study. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available