Effectiveness of Controlled-Release Morphine for Chronic Neuropathic Pain After Spinal Cord Injury

NCT00488969 | Completed Phase 2 DMC

• 2 other identifiers: H133N060027GCO # 90-135
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

We would like to learn if a medicine called "modified-release morphine sulfate" (Avinza) helps reduce Spinal Cord Injury (SCI)-related pain that has lasted a long time. "Modified-release" means that the medicine in the capsules is slowly released to the body, instead of being released all at once. Avinza is approved by the Food and Drug Administration for the treatment of pain, but we do not know how effective Avinza is in reducing SCI-related pain.

Conditions

Neuropathic Pain; Spinal Cord Injury

Keywords

Morphine; Chronic Pain; Spinal Cord Injury; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Pain severity

  Pain severity rated using a 0-10 Numeric Rating Scale (NRS)

  Average of daily ratings over 14 days

Secondary Outcomes (10)

• Short McGill Pain Questionnaire (modified) (SF-McGill)

  up to 14 weeks

• Opioids cognitive effects scale

  up to 14 weeks

• Patient Generated Index for activity (PGI)

  up to 14 weeks

• Daily number of attacks of paroxysmal pain

  up to 14 weeks

• Quantitative sensory testing

  up to 14 weeks

Study Arms (2)

Modified-release morphine then Placebo

ACTIVE COMPARATOR

up to a ceiling dose of 120 mg

Drug: Modified-release morphine; Drug: Placebo

Placebo then modified-release morphine

PLACEBO COMPARATOR

Matching placebo

Drug: Modified-release morphine; Drug: Placebo

Interventions

Modified-release morphine DRUG

During the first three weeks of each treatment (drug or placebo), the dose will be escalated toward a maximally tolerated dose or a dose sufficient to eliminate pain (up to a ceiling dose of 120 mg), whichever is reached first. During the entire fourth and fifth week of each period, subjects will receive their maximally tolerated dose of study medication. During the sixth and seventh weeks, they will undergo a seven-day dose tapering and a seven-day complete washout of the study drug.

Also known as: Modified-release morphine sulfate

Modified-release morphine then Placebo; Placebo then modified-release morphine

Placebo DRUG

Modified-release morphine then Placebo; Placebo then modified-release morphine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 65
• Diagnosis of traumatic spinal cord injury
• Neuropathic pain (pain related to the nervous system) rated at least 4 on a 11-point numeric rating scale at the time of screening
• Pain classified as at level radicular pain (ALRP), at level central pain (ALCP) or below level central pain (BLCP).
• Pain that is present regularly for at least 3 months prior to enrollment, in spite of medication or other pain treatment. This pain can be paroxysmal in nature (attacks of pain).
• Ability to understand instructions and reliably provide pain assessments
• Willingness to stop current opioid medications, if any
• If a female with childbearing potential, using an approved method of birth control (intrauterine device (IUD), barrier protection, a contraceptive implantation system or injection (Norplant® or Depo-Provera®), oral contraceptive pills, or celibacy)

You may not qualify if:

• A known sensitivity to opioids
• A history of substance or alcohol abuse within the past 2 years
• A need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period
• Other chronic pain that cannot be differentiated from ALCP, ALRP, or BLCP
• A history of active cancer, excluding basal carcinoma of the skin, in the past 3 years
• Serum creatinine levels \>= 2.5 mg/dl or hepatic (liver) dysfunction with serum ALT, AST, GGT, or total bilirubin \>= 3 times the upper limit of normal
• Participation in any drug study in the last three months
• Currently pregnant or breastfeeding

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• U.S. Department of Education: collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Neuralgia; Spinal Cord Injuries; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Thomas Bryce, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 19, 2007
• First Posted: June 20, 2007
• Study Start: July 1, 2007
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

US (1)