A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2012-005495-34-SE
• Date of registration: 29/09/2015
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc, 235 East 42nd Street, New York, NY 10017
• Public title: A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN
• Scientific title: A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO AND ACTIVE-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN ADULT SUBJECTS WITH CHRONIC LOW BACK PAIN
• Date of first enrolment: 25/01/2016
• Target sample size: 1800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005495-34
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: yes Other: no Number of treatment arms in the trial: 4
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Canada, Denmark, France, Hungary, Japan, Korea, Republic of, Spain, Sweden, United States

Contacts

• Name: ClinicalTrials.gov call Center
• Affiliation: Pfizer Inc

• Name: ClinicalTrials.gov call Center
• Affiliation: Pfizer Inc

Key inclusion & exclusion criteria

Inclusion criteria:
-Chronic low back pain =3 months in duration, Quebec Task Force in Spinal Disorders class 1 or 2, with documented history of previous inadequate treatment response to at least 3 different categories of agents commonly used and generally considered effective for the treatment of chronic low back pain.

Refer to protocol for full list of inclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1530
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 270

Exclusion criteria:
-Diagnosis of osteoarthritis of the knee or hip as defined by the American College of Rheumatology (ACR) criteria.
Subjects who have Kellgren Lawrence Grade =2 radiographic evidence of hip or Grade =3 radiographic evidence of knee osteoarthritis will be excluded;
-History or radiographic evidence of other diseases that could confound efficacy or safety assessments (e.g., rheumatoid arthritis).
-History or radiographic evidence of orthopedic conditions that may increase the risk of, or confound assessment of joint safety conditions during the study.
-Signs and symptoms of clinically significant cardiac disease within 6 months of the study (e.g., unstable angina, myocardial infarction, resting bradycardia, poorly controlled or untreated hypertension) as defined in the protocol or subjects with any other cardiovascular illness that in the opinion of the Investigator would render a subject unsuitable to participate in the study
-History, diagnosis, or signs and symptoms of clinically significant neurological disease (e.g., transient ischemic attack, stroke, peripheral or autonomic neuropathy) as specified in the protocol
-Subjects with evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol.

Please refer to the protocol for the remaining exclusion criteria


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

CHRONIC LOW BACK PAIN
MedDRA version: 19.0 Level: LLT Classification code 10024891 Term: Low back pain System Organ Class: 100000004859

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Product Name: Tanezumab
Product Code: PF-04383119
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Tanezumab
CAS Number: 880266-57-9
Current Sponsor code: PF-04383119
Other descriptive name: RI624, RN624
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Product Name: Tanezumab
Product Code: PF-04383119
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Tanezumab
CAS Number: 880266-57-9
Current Sponsor code: PF-04383119
Other descriptive name: RI624, RN624
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use

Product Name: Tramadol
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Tramadol
CAS Number: 27203-92-5
Other descriptive name: TRAMADOL HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Modified-release tablet
Route of administration of the placebo: Oral use

Product Name: Tramadol
Pharmaceutical Form: Modified-release tablet
INN or

Primary Outcome(s)

Primary end point(s): Change from Baseline to Week 16 in the daily average Low Back Pain Intensity (LBPI) score as measured by an 11-point Numeric Rating Scale for tanezumab vs placebo.

Secondary Objective: -Evaluate the long-term safety of tanezumab 10 mg and 5 mg SC administered every 8 weeks (7 administrations);

-Estimate the long-term analgesic efficacy of tanezumab 10 mg and 5 mg SC administered every 8 weeks (7 administrations) up to Week 56;

- Compare the analgesic efficacy of tanezumab 10 mg SC administered every 8 weeks relative to an active comparator (oral tramadol PR) at Week 16.

Main Objective: Demonstrate superior analgesic efficacy of tanezumab 10 mg and 5 mg administered subcutaneously (SC) every 8 weeks compared to placebo at Week 16.

Timepoint(s) of evaluation of this end point: Please refer to the protocol

Secondary Outcome(s)

Secondary end point(s): -Key Secondary Endpoints:
-Change from Baseline to Week 16 in the Roland Morris Disability Questionnaire(RMDQ) for tanezumab vs placebo;
-Change from Baseline to Week 16 in the daily average LBPI score as measured by an 11-point Numeric Rating Scale for tanezumab vs. tramadol PR.

Timepoint(s) of evaluation of this end point: Please refer to the protocol

Secondary ID(s)

A4091059

Source(s) of Monetary Support

Pfizer Inc, 235 East 42nd Street, New York, NY 10017

Ethics review

Status: Approved
Approval date:
Contact: