Single-arm Study to Assess the Safety of Hydromorphone HCl by Intrathecal Administration
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Purpose
The purpose of this study is to evaluate the long-term safety of hydromorphone hydrochloride administered by intrathecal delivery.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Pain |
Drug: Hydromorphone Hydrochloride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3, Open-Label, Single-Arm Study To Assess The Safety Of Hydromorphone Hydrochloride Delivered By Intrathecal Administration |
- Frequency of Adverse Events during a 12-month period of treatment with intrathecal hydromorphone. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]The primary endpoint of this trial is Safety. There is no formal efficacy assessment planned in this open-label safety study. The patient status will be assessed by providing a VASPI score at each study visit. Subjects who drop out provide a VASPI assessment prior to discontinuation from the study.
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Hydromorphone Hydrochloride
Hydromorphone hydrochloride for intrathecal administration, 12 months safety evaluation
|
Drug: Hydromorphone Hydrochloride
Opioid for chronic pain
Other Names:
|
Detailed Description:
This is an open-label, single-arm safety study to evaluate the safety of hydromorphone hydrochloride given by continuous intrathecal infusion using an implantable pump device. This study will enroll both subjects on a current opioid intrathecal medication as well as naïve subjects now current on intrathecal opioid medications. All subjects currently on intrathecal opioid treatment will be converted from their current intrathecal therapy to intrathecal hydromorphone hydrochloride according to standard medical practice. After an optimal dose for pain relief is achieved, subjects will remain on therapy for a total of 12 months or until discontinuation from the study. During this continuous dosing period, dose adjustments (up or down) are permitted to manage pain or side effects provided a maximum dose of 5 mg/day is not exceeded. Subjects will be assessed for pain intensity using a VASPI instrument at each study visit.
Subjects will be evaluated for side effects and clinical complications associated with the use of intrathecal hydromorphone. Events will be classified by intrathecal drugs used and concentrations.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects must be at least 18 years of age and no more than 75 years old.
- Clinically diagnosed with severe chronic pain for at least a 6-month period.
- Subject is reasonably expected to benefit from intrathecal pain medication and has a programmable implantable intrathecal pump or meets clinical criteria for implantation of an intrathecal pump per Standard of Care.
- Subject agrees to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study medication prescribed by the investigator.
- Subject must be cognitively intact and, in the opinion of the investigator, capable of participation in the trial.
- Female subjects of child-bearing potential must agree to use a medically acceptable and effective double-barrier method of birth control.
- Subjects who can receive an MRI if required by the study protocol.
- Provides written Ethics Committee approved informed consent.
- Willing to comply with all study procedures and requirements.
Exclusion Criteria:
- Women who are pregnant or breast-feeding
- Subject has any known or suspected allergy to hydromorphone hydrochloride or to the materials of the infusion pump or intrathecal catheter.
- Subjects who show signs of active systemic infection.
- Subjects with a metastatic cancer to the spinal canal or a known central nervous system contraindication to intrathecal therapy.
- Subjects have a condition requiring diathermy procedures.
- Subject has a life expectancy of less than 12 months.
- Subjects who are unable or unwilling to return to all of the required follow-up visits.
- As a result of medical review and physical examination, the Investigator considers the subject unfit for the study.
Contacts and Locations| Contact: Richard E Lowenthal, MSc | 858-335-1300 | richard@pacificlinkconsulting.com |
| Contact: Sarina Tanimoto, MD | 858-227-3008 | sarina@pacificlinkconsulting.com |
| United States, North Carolina | |
| The Center for Clinical Research | Not yet recruiting |
| Winston-Salem, North Carolina, United States, 27103 | |
| Contact: Richard L Rauck, MD | |
| Principal Investigator: Richard L Rauck, MD | |
| Principal Investigator: | Richard Rauck, MD | Carolinas Pain Institute |
More Information
No publications provided
| Responsible Party: | CNS Therapeutics |
| ClinicalTrials.gov Identifier: | NCT01709747 History of Changes |
| Other Study ID Numbers: | CNS-HYD202US |
| Study First Received: | September 4, 2012 |
| Last Updated: | October 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by CNS Therapeutics:
|
Hydromorphone Hydrochloride Hydromorphone Pain Chronic Pain |
Implantable Pump Pump Intrathecal |
Additional relevant MeSH terms:
|
Hydromorphone 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 |
ClinicalTrials.gov processed this record on May 19, 2013