A Clinical Trial to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain (ACT11705)

Sanofi

Status and phase: Terminated; Phase 2

Conditions: Breakthrough Cancer Pain; Pain

Treatments: Drug: SSR411298; Drug: Placebo (for SSR411298)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01439919

2011-002557-56 (EudraCT Number)

U1111-1115-3390 (Other Identifier)

ACT11705

Details and patient eligibility

About

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.

Full description

The total study duration for a participant is 6 weeks (1-week screening, 4-week treatment and 1-week post-treatment follow-up).

Participants continue to receive WHO Step 2 or 3 cancer pain treatment as background therapy.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups, including a placebo group

SSR411298 200 mg

Experimental group

Description:

SSR411298 200 mg, one tablet once daily for 4 weeks

Treatment:

Drug: SSR411298

Placebo

Placebo Comparator group

Description:

Placebo (for SSR411298), one tablet once daily for 4 weeks

Treatment:

Drug: Placebo (for SSR411298)