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Study of RNS60 on Pain and Function After Hip Labral Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02005523
Recruitment Status : Withdrawn
First Posted : December 9, 2013
Last Update Posted : February 6, 2015
Information provided by (Responsible Party):
Revalesio Corporation

Brief Summary:
The purpose of this study is to see if use of RNS60 during hip labral repair surgery decreases pain and improves functional capacity post-operation.

Condition or disease Intervention/treatment Phase
Hip Labral Tear Drug: RNS60 Drug: Saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Study of RNS60 on Post-operative Pain and Function in Patients Undergoing Hip Labral Repair or Reconstruction Surgery
Actual Primary Completion Date : October 2014

Arm Intervention/treatment
Experimental: RNS60 Drug: RNS60
Placebo Comparator: Saline Drug: Saline

Primary Outcome Measures :
  1. Assessment of post-operative pain [ Time Frame: 1 week ]
    Comparison of scores from validated pain scales from post-surgery to one week.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Accepts Healthy Volunteers:   No

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02005523

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United States, Washington
Tacoma, Washington, United States
Sponsors and Collaborators
Revalesio Corporation

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Responsible Party: Revalesio Corporation Identifier: NCT02005523     History of Changes
Other Study ID Numbers: 07.1.1.H2
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
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Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmaceutical Solutions