Efficacy and Safety Trial to Evaluate the Sufentanil NanoTab® PCA System/15 Mcg for Post-Operative Pain in Patients After Knee or Hip Replacement Surgery
This study has been completed.
Sponsor:
AcelRx Pharmaceuticals, Inc.
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01660763
First received: August 7, 2012
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to compare the efficacy and safety of the Sufentanil NanoTab PCA System/15 mcg to the Placebo Sufentanil NanoTab PCA System for the management of acute post-operative pain after total unilateral knee or total unilateral hip replacement surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Post Operative Pain |
Drug: Sufentanil NanoTab PCA System/15 mcg Drug: Placebo Sufentanil NanoTab PCA System |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | P3 - A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of the Sufentanil NanoTab® PCA System/15 Mcg for the Treatment of Post-Operative Pain in Patients After Knee or Hip Replacement Surgery |
Resource links provided by NLM:
MedlinePlus related topics:
Hip Replacement
Drug Information available for:
Sufentanil citrate
U.S. FDA Resources
Further study details as provided by AcelRx Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Time-weighted summed pain intensity difference (SPID) over the 48-hour study period (SPID48). [ Time Frame: 48-hours ] [ Designated as safety issue: No ]
| Enrollment: | 426 |
| Study Start Date: | August 2012 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sufentanil NanoTab PCA System/15 mcg |
Drug: Sufentanil NanoTab PCA System/15 mcg
15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
|
| Placebo Comparator: Placebo Sufentanil NanoTab PCA System |
Drug: Placebo Sufentanil NanoTab PCA System
Placebo NanoTab taken sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female patients who are 18 years of age or older
- Patients who are scheduled for an elective cemented or uncemented total unilateral knee replacement or total unilateral hip replacement, under general or spinal anesthesia that does not include use of an intrathecal opioid
- Post-surgical patients who have been admitted to the PACU and are expected to remain hospitalized and to have acute post-operative pain requiring parenteral opioids for at least 48 hours after surgery
Exclusion Criteria:
- Patients who have undergone a replacement of the same knee or hip
- Patients who have taken an opioid for more than 30 consecutive days, at a daily dose of 15 mg or more of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of Vicodin®, Norco®, Lortab® with 5 mg hydrocodone per tablet)
- Patients with an allergy or hypersensitivity to opioids
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01660763
Locations
| United States, Florida | |
| Orthopedic Center of Vero Beach | |
| Vero Beach, Florida, United States, 32960 | |
Sponsors and Collaborators
AcelRx Pharmaceuticals, Inc.
Investigators
| Study Director: | Pamela Palmer, M.D., PhD | Chief Medical Officer, AcelRx Pharmaceuticals, Inc. |
More Information
No publications provided
| Responsible Party: | AcelRx Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01660763 History of Changes |
| Other Study ID Numbers: | AcelRx IAP311 |
| Study First Received: | August 7, 2012 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Sufentanil Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Adjuvants, Anesthesia Narcotics Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on May 23, 2013