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

NCT01439919 | Terminated Phase 2 DMC

• 3 other identifiers: ACT117052011-002557-56U1111-1115-3390
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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). 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

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (13)

• Change from baseline in Brief Pain Inventory Short-Form (BPI-SF) scores

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

• Responder rates

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

• Breakthrough pain frequency

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

• Opioid consumption expressed as the morphine-equivalent dose per day

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

• Rescue medication consumption expressed as the number of rescue medication doses per day

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

Study Arms (2)

SSR411298 200 mg

EXPERIMENTAL

SSR411298 200 mg, one tablet once daily for 4 weeks

Drug: SSR411298

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo (for SSR411298)

Interventions

SSR411298 DRUG

Form: tablet Route: oral administration with food

SSR411298 200 mg

Placebo (for SSR411298) DRUG

Form: tablet Route: oral administration with food

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Investigational Site Number 840006

Flat Rock, North Carolina, 28731, United States

Location

Investigational Site Number 840005

Canton, Ohio, 44718, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 23, 2011
• Study Start: January 1, 2012
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 21, 2013

Record last verified: 2013-03

Locations

US (2)