Single Injection of REGN475/SAR164877 in Treatment of Vertebral Fracture Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-01-31

Brief Summary

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Primary objective was to demonstrate the activity of REGN475/SAR164877 in reducing the pain associated with vertebral fracture.

Secondary objectives were:

* to assess the safety and tolerability of REGN475/SAR164877 in patients with vertebral fracture pain;
* to characterize the pharmacokinetic and immunogenicity profiles of REGN475/SAR164877 in this population.

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Detailed Description

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The duration of the study period for each participant was up to 13 weeks, including a screening period up to 5 days, and 12-week follow-up after the injection.

Conditions

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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REGN475/SAR164877

REGN475/SAR164877, single injection, dose depending on the participant's body weight

Group Type EXPERIMENTAL

REGN475/SAR164877

Intervention Type DRUG

Pharmaceutical form: solution

Route of administration: intravenous infusion over 30 minutes

Placebo

Placebo (for REGN475/SAR164877), single injection

Group Type PLACEBO_COMPARATOR

Placebo (for REGN475/SAR164877)

Intervention Type DRUG

Pharmaceutical form: solution

Route of administration: intravenous infusion over 30 minutes

Interventions

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REGN475/SAR164877

Pharmaceutical form: solution

Route of administration: intravenous infusion over 30 minutes

Intervention Type DRUG

Placebo (for REGN475/SAR164877)

Pharmaceutical form: solution

Route of administration: intravenous infusion over 30 minutes

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- Moderate to severe pain due to non-traumatic vertebral fracture associated with osteoporosis.

Exclusion Criteria

* Mild pain score on the Pain Intensity-Numeric Rating Scale \[PI-NRS\] at screening and randomization visits;
* Narcotic addiction;
* Post-fracture vertebral instability;
* Unwillingness to use study-defined rescue analgesia exclusively.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No