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

NCT01439919 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2013-03-21

No results posted yet for this study

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).

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

  • Pain
  • Breakthrough Cancer Pain

Interventions

DRUG

SSR411298

Form: tablet Route: oral administration with food

DRUG

Placebo (for SSR411298)

Form: tablet Route: oral administration with food

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01439919 on ClinicalTrials.gov