Trials / Completed
CompletedNCT01185470
The Clinical Evaluation of Implantable Pump System For Safety And Delivery Accuracy In Patients Requiring Intrathecal Administration Of Morphine Sulfate For Chronic Pain
THE CLINICAL EVALUATION OF IMPLANTABLE PUMP SYSTEM FOR SAFETY AND DELIVERY ACCURACY IN PATIENTS REQUIRING INTRATHECAL ADMINISTRATION OF MORPHINE SULFATE FOR CHRONIC PAIN
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Medallion Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
• The objectives of this study are to confirm the medication delivery accuracy of the Infusion System, LLC Implantable Drug Delivery System (IDDS) with Patient Controlled Analgesia for intrathecal delivery of morphine sulfate for pain control, and to determine the safety profile of the system with PCA for intrathecal delivery of morphine sulfate for pain control.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Implantation of Morphine Sulfate delivering programmable pump | Patients with chronic pain responsive to intrathecal opioid analgesia as demonstrated in a morphine trial or patients with a previous successful intrathecal opioid therapy with an implantable pump will undergo implantation of pump for intrathecal delivery of Morphine Sulfate. |
Timeline
- Start date
- 2011-02-01
- Primary completion
- 2015-01-01
- Completion
- 2016-07-01
- First posted
- 2010-08-20
- Last updated
- 2017-04-24
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01185470. Inclusion in this directory is not an endorsement.