You are here

A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee

Last updated on October 4, 2018

FOR MORE INFORMATION
Study Location
The Birmingham Pain Center
Birmingham, Alabama, 35244 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Osteoarthritis, Chronic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subject is 21 years of age or older

- Subject is either not of childbearing potential OR subject must use an acceptable
method of birth control if of childbearing potential

- Negative pregnancy test if female of childbearing potential

- Subject is in general good health

- Subject required treatment of joint pain within the last 90 days

- Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subject has a documented history of allergic reaction or intolerance to morphine or
other opioids

- Subject is pregnant or breast-feeding

- Subject is receiving systemic chemotherapy

- Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence

- Subject has history of major depressive disorder not controlled with medication

- Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the
symptoms of OA

- Subject has active gastrointestinal disease, with the exception of gastroesophageal
reflux disease (GERD)

- Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory
arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory
arthritis

NCT00420992
Pfizer
Completed
A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Cervical Pain, Neuropathic Pain, Radiating Pain
NCT02868359
All Genders
20+
Years
Multiple Sites
Chronic Myeloid Leukaemia
NCT02546375
All Genders
0+
Years
Multiple Sites
Pain
NCT02863575
All Genders
16+
Years
Salt Lake City, Utah
A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Efficacy Study of Kadian NT (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee
The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.
The primary objective of this study is to evaluate the efficacy of ALO-01 compared with placebo for the treatment of chronic moderate to severe pain (focusing on osteoarthritis of the hip or knee) as measured by mean change in diary Brief Pain Inventory (BPI) score of average pain (daily scores of average pain averaged over 7 days) from randomization to 12 weeks following randomization.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Osteoarthritis
  • Chronic Pain
  • Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
    capsules, up to 80 mg bid
    Other Name: Embeda
  • Drug: Placebo
    capsules, bid
  • Experimental: ALO-01
    Up to 80 mg twice a day (bid)
    Intervention: Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release)
  • Placebo Comparator: Placebo
    Twice a day (bid)
    Intervention: Drug: Placebo
Setnik B, Pixton GC, Webster LR. Safety profile of extended-release morphine sulfate with sequestered naltrexone hydrochloride in older patients: pooled analysis of three clinical trials. Curr Med Res Opin. 2016;32(3):563-72. doi: 10.1185/03007995.2015.1131153. Epub 2016 Jan 26.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
547
November 2007
November 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject is 21 years of age or older
  • Subject is either not of childbearing potential OR subject must use an acceptable method of birth control if of childbearing potential
  • Negative pregnancy test if female of childbearing potential
  • Subject is in general good health
  • Subject required treatment of joint pain within the last 90 days
  • Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee

Exclusion Criteria:

  • Subject has a documented history of allergic reaction or intolerance to morphine or other opioids
  • Subject is pregnant or breast-feeding
  • Subject is receiving systemic chemotherapy
  • Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence
  • Subject has history of major depressive disorder not controlled with medication
  • Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the symptoms of OA
  • Subject has active gastrointestinal disease, with the exception of gastroesophageal reflux disease (GERD)
  • Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory arthritis
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00420992
ALO-KNT-301
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: James B. Jones, MD, PharmD Alpharma Pharmceuticals
Pfizer
September 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now