Evaluating the Efficacy and Safety of Extended Release Hydromorphone (Exalgo) in Patients With Neuropathic Pain

NCT01207596 | Completed Phase 4 Results

• 1 other identifier: EX-NP2010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if Exalgo (r) is beneficial for the patients with neuropathic pain.

Conditions

Neuropathic Pain

Keywords

Pain; Neuropathy; Neuropathic Pain; Hydromorphone

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale

  The primary efficacy measure was the change from baseline to end of study on question #5 ("average pain") of the Brief Pain Inventory (BPI): "Please rate your pain by marking the box beside the number that best describes your pain on the average," where 0 = no pain and 10 = pain as bad as you can imagine.

  Baseline visit to Week 12 or last visit

Secondary Outcomes (6)

• Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #3: the Number That Best Describes Your Pain at Its Worst in the Last 24 Hours

  Baseline visit to Week 12 or last visit

• Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #4: the Number That Best Describes Your Pain at Its Least in the Last 24 Hours

  Baseline visit to Week 12 or last visit

• Change From Baseline in the Average Pain Over the Last 24 Hrs on the Brief Pain Inventory (BPI) Scale Question #6: the Number That Tells How Much Pain You Have Right Now

  Baseline visit to Week 12 or last visit

• Sleep Quality Assessment (SQA)

  Baseline visit to Week 12 or last visit

• Pain Quality Assessment Scale (PQAS)

  Baseline visit to 12 weeks visit

Study Arms (1)

Hydromorphone

ACTIVE COMPARATOR

Drug: Hydromorphone

Interventions

Hydromorphone DRUG

Oral hydromorphone extended release, once daily

Also known as: EXALGO (R)

Hydromorphone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals with chronic pain of more than 6 months duration
• pain is determined to be secondary to a documented neuropathy
• patients who are tolerant of opiates (60 mg of morphine or equivalent for at least one week)
• male or female patients aged 18-75 yrs and have signed a written informed consent form and privacy statement
• female patients of child-bearing potential must be using an acceptable form of birth control

You may not qualify if:

• pregnant or lactating women
• allergy to morphine or its derivatives
• history of alcohol or substance abuse in the last 3 yrs
• participation in any other clinical trial in the last 30 days
• uncontrolled pain
• patient who is deemed to be medically unstable by principal investigator
• history of severe lung disease or asthma that is deemed medically significant by principal investigator

Sponsors & Collaborators

• International Clinical Research Institute: lead

Study Sites (1)

International Clinical Research Institute

Leawood, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Neuralgia; Pain

Interventions

Hydromorphone

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Srinivas Nalamachu
• Organization: International Clinical Research Institute

nalamachu@yahoo.com

913-317-5300

Study Officials

• Srinivas Nalamachu, MD

  International Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 20, 2010
• First Posted: September 23, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 20, 2012
• Results First Posted: June 20, 2012

Record last verified: 2012-05

Locations

US (1)