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A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain


Phase 2
18 Years
N/A
Not Enrolling
Both
Pain, Breakthrough Cancer Pain

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Trial Information

A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Assess the Clinical Benefit of SSR411298 as Adjunctive Treatment for Persistent Cancer Pain


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.

Inclusion Criteria


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Change from baseline in average Numeric Rating Scale (NRS) pain intensity score

Outcome Description:

The NRS is an 11-category descriptive anchor scale that is one of the most frequently employed and accepted scales for pain evaluation. Score ranges from 0 [no pain] to 10 [worst possible pain]. Average NRS score is defined as the average of pain intensity scores measured daily by NRS during a week.

Outcome Time Frame:

5 weeks (from D-7 (seven days before randomization) up to D28)

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

ACT11705

NCT ID:

NCT01439919

Start Date:

January 2012

Completion Date:

February 2012

Related Keywords:

  • Pain
  • Breakthrough Cancer Pain

Name

Location

Investigational Site Number 840005Cincinnati, Ohio  45267-0542
Investigational Site Number 840006Flat Rock, North Carolina  28731