Trials / Completed
CompletedNCT01709721
Safety and Efficacy Study of Hydromorphone Hydrochloride by Intrathecal Administration
A Controlled, Two-Arm, Parallel Group, Randomized Withdrawal Study to Assess the Safety and Efficacy of Hydromorphone Hydrochloride Delivered by Intrathecal Administration Using a Programmable Implantable Pump
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 153 (actual)
- Sponsor
- Piramal Critical Care, Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the safety and efficacy of hydromorphone hydrochloride by intrathecal administration using a programmable implantable pump.
Detailed description
A Controlled, Two-Arm, Parallel Group, Randomized Withdrawal Study to Assess the Safety and Efficacy of Hydromorphone Hydrochloride Delivered by Intrathecal Administration Using a Programmable Implantable Pump
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hydromorphone Hydrochloride | Opioid for chronic pain |
| DEVICE | Programmable Implantable pump | Programmable Implantable pump delivering intrathecal hydromorphone |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2018-02-01
- Completion
- 2018-02-01
- First posted
- 2012-10-18
- Last updated
- 2021-11-04
- Results posted
- 2021-08-17
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01709721. Inclusion in this directory is not an endorsement.