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Status:

TERMINATED

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

Lead Sponsor:

Sanofi

Conditions:

Pain

Breakthrough Cancer Pain

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

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). S...

Detailed 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 ...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    January 1 2012

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2012

    Estimated Enrollment :

    5 Patients enrolled

    Trial Details

    Trial ID

    NCT01439919

    Start Date

    January 1 2012

    End Date

    February 1 2012

    Last Update

    March 21 2013

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Investigational Site Number 840006

    Flat Rock, North Carolina, United States, 28731

    2

    Investigational Site Number 840005

    Canton, Ohio, United States, 44718