A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 Mcg to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
This study has been completed.
Sponsor:
AcelRx Pharmaceuticals, Inc.
Information provided by (Responsible Party):
AcelRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01539538
First received: February 22, 2012
Last updated: February 28, 2013
Last verified: April 2012
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Purpose
The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.
| Condition | Intervention | Phase |
|---|---|---|
|
Post-Operative Pain |
Drug: Sufentanil NanoTab PCA System/15 mcg Drug: morphine IV PCA |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 Mcg to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain |
Resource links provided by NLM:
Further study details as provided by AcelRx Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Patient satisfaction with method of pain control [ Time Frame: 48 hours after first dose ] [ Designated as safety issue: No ]Patient's response on the Patient Global Assessment (PGA) of method of pain control over the 48-hour study period using the 4-point scale where 1=poor, 2=fair, 3=good and 4=excellent. The primary efficacy parameter is the proportion of patients who responded "good" or "excellent" on the PGA of method of pain control over the 48-hour study period.
| Estimated Enrollment: | 352 |
| Study Start Date: | April 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (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
|
| Active Comparator: morphine IV PCA |
Drug: morphine IV PCA
1 mg morphine administered IV q 6 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 or older
- Patients who are scheduled to undergo an open abdominal surgery (including laparoscopic-assisted), total knee or total hip replacement surgery under general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation.
- 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 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
- Female patients who are pregnant or breast-feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539538
Locations
| United States, Alabama | |
| Eliza Coffee Memorial Hospital | |
| Florence, Alabama, United States, 35630 | |
| Drug Research and Analysis Corp | |
| Montgomery, Alabama, United States, 36106 | |
| Shoals Medical Trials, Inc | |
| Sheffield, Alabama, United States, 35660 | |
| United States, Arizona | |
| Arizona Research Center | |
| Phoenix, Arizona, United States, 85023 | |
| United States, California | |
| Lotus Clinical Research | |
| Pasadena, California, United States, 91105 | |
| Thorton Hospital | |
| San Diego, California, United States, 92037 | |
| United States, Florida | |
| Florida Research Associates, LLC | |
| DeLand, Florida, United States, 32720 | |
| River City Clinical Research | |
| Jacksonville, Florida, United States, 32207 | |
| Pensacola Research Consultants, Inc | |
| Pensacola, Florida, United States, 32504 | |
| Gulfcoast Research Institute | |
| Sarasota, Florida, United States, 34232 | |
| Phoenix Clinical Research LLC | |
| Tamarac, Florida, United States, 33321 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| The Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Tennessee | |
| Access Clinical Trials | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Endeavor Clinical Trials, PA | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Jean Brown Research | |
| Salt Lake City, Utah, United States, 84124 | |
Sponsors and Collaborators
AcelRx Pharmaceuticals, Inc.
Investigators
| Study Director: | Pamela Palmer, M.D., PhD | AcelRx Pharmaceuticals, Inc. |
More Information
No publications provided
| Responsible Party: | AcelRx Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT01539538 History of Changes |
| Other Study ID Numbers: | IAP309 |
| Study First Received: | February 22, 2012 |
| Last Updated: | February 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AcelRx Pharmaceuticals, Inc.:
|
Adult post-operative inpatients who are expected to require parenteral opioid analgesia for at least 48 hours after open abdominal surgery or hip/knee replacement surgery |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Morphine 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 Narcotics Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on May 16, 2013