Study of Embeda (Kadian NT, ALO-01) in Subjects With Chronic Moderate to Severe Nonmalignant Pain

Pain Clinical Trial

Official title:

A Long-Term, Open-Label Safety Study of ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Chronic Moderate to Severe Nonmalignant Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00415597
• Other study ID #: ALO-KNT-302
• Status: Completed
• Phase: Phase 3
• First received: December 21, 2006
• Last updated: September 13, 2013
• Start date: December 2006
• Est. completion date: March 2008

Study information

• Verified date: September 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Open-Label, Safety Study to evaluate the long-term safety of Kadian NT (ALO-01) administered for up to 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 467
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Subject 18-70 years of age

• Subject agrees to refrain from taking any opioid medications other than study medication during study period.

• History of chronic moderate to severe pain caused by a nonmalignant condition for at least 3 months prior to baseline

Exclusion Criteria:

• Subject has a documented history of allergic reaction or clinically significant intolerance to morphine or other opioids, such that treatment with morphine is contraindicated.

• Subject is pregnant or breast-feeding.

• Subject is receiving chemotherapy, or has an active malignancy of any type or has been diagnosed with cancer within the past three years (excluding squamous or basal cell carcinoma of the skin).

• Subject has a documented history of drug abuse/dependence/misuse or narcotic analgesic abuse/dependence/misuse within five years prior to the Baseline Visit.

• Subject has a Body Mass Index (BMI)>45kg/m2.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
capsules, available dosage strengths 20, 30, 40, 50, 60, 80, and 100 mg morphine sulfate with 4% by weight naltrexone hydrochloride given once or twice daily

Locations

Country	Name	City	State
United States	Barbara McGuire, MD	Albuquerque	New Mexico
United States	Robert Burton, MD	Anaheim	California
United States	Steve Sitar, MD	Anaheim	California
United States	Walter Chase, MD	Austin	Texas
United States	Arturo Palencia, MD	Bakersfield	California
United States	Adam Karnes, MD	Beverly Hills	California
United States	Michael Gibson, MD	Birmingham	Alabama
United States	Raymond Tidman, MD	Blue Ridge	Georgia
United States	Patrick Box, MD	Charlotte	North Carolina
United States	Azazuddin Ahmed, MD	Chicago	Illinois
United States	Gregory Gottschlich, MD	Cincinatti	Ohio
United States	Bruce Corser, MD	Cincinnati	Ohio
United States	Steven Croft, MD	Delray Beach	Florida
United States	Joseph Dunn, MD	Eugene	Oregon
United States	Steven Elliott, MD	Evansville	Indiana
United States	Douglas Haselwood, MD	Fair Oaks	California
United States	Mel Lucas, MD	Florissant	Missouri
United States	William Travis Ellison, MD	Greer	South Carolina
United States	James Meli, DO	Henderson	Nevada
United States	Roberto Rodriquez, MD	Hialeah	Florida
United States	Orlando Florete, MD	Jacksonville	Florida
United States	Michael Link, MD	Kissimmee	Florida
United States	William Smith, MD	Knoxville	Tennessee
United States	Miguel Trevino, MD	Largo	Florida
United States	Stephen Miller, MD	Las Vegas	Nevada
United States	Vrijendra Kumar, MD	Las Vegas	Nevada
United States	Arnold Weil	Marietta	Georgia
United States	Marvin Tark	Marietta	Georgia
United States	Lee Carter, MD	Milan	Tennessee
United States	Randale Sechrest, MD	Missoula	Montana
United States	Arthur Elkind, MD	Mount Vernon	New York
United States	David Miller, MD	North Dartmouth	Massachusetts
United States	Tanna Shaw, MD	Oklahoma City	Oklahoma
United States	John Jacobson, MD	Omaha	Nebraska
United States	Diego Torres II, MD	Ormond Beach	Florida
United States	Jenecsis Castro-Skoglund, MD	Peoria	Illinois
United States	Michael Loes, MD	Phoenix	Arizona
United States	Steven Siwek, MD	Phoenix	Arizona
United States	Martin Hale, MD	Plantation	Florida
United States	Andrew Klymiuk, MD	Richardson	Texas
United States	Richard Eckert, MD	Roanoke	Virginia
United States	Rebecca Baumbach, MD	Saginaw	Michigan
United States	Webster Lynn, MD	Salt Lake City	Utah
United States	Francis Burch, MD	San Antonio	Texas
United States	Suzanne Gazda, MD	San Antonio	Texas
United States	Randall Brewer, MD	Shreveport	Louisiana
United States	Adnan Dahdul, MD	Springfield	Massachusetts
United States	Anthony Margherita, MD	St. Louis	Missouri
United States	Margarita Nunez, MD	St. Petersburg	Florida
United States	Mary Stedman, MD	Tampa	Florida
United States	Allan Soo, MD	Tempe	Arizona
United States	Lawrence Levinson, MD	Tipton	Pennsylvania
United States	Robert Kalb, MD	Toledo	Ohio
United States	Leah Schmidt, DO	Tucson	Arizona
United States	Christopher Colopinto, MD	Voorhees	New Jersey
United States	John Peppin, DO	West Des Moines	Iowa
United States	Richard Rauck, MD	Winston-Salem	North Carolina
United States	Thomas Littlejohn III, MD	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects With Treatment Emergent Adverse Events	Number of subjects with adverse events (any unfavorable and unintended sign, symptom, or disease temporally associated with the use of the product whether or not related to the product).	up to 12 months	Yes
Secondary	Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain	Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.	12 weeks	No
Secondary	Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain	Percent change in pain intensity scale. Average pain intensity over last 24 hours rated at each visit from 0=no pain to 10=worst pain.	52 weeks	No