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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00415597
Recruitment Status : Completed
First Posted : December 25, 2006
Results First Posted : October 29, 2009
Last Update Posted : September 20, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Intervention Drug: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride ER)
Enrollment 467
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ALO-01
Hide Arm/Group Description [Not Specified]
Period Title: Enrollment
Started 467
Completed 465
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Protocol Violation             1
Period Title: Treatment
Started 465
Completed 160
Not Completed 305
Reason Not Completed
Adverse Event             110
Lack of Efficacy             39
Protocol Violation             67
Physician Decision             3
Withdrawal by Subject             51
Lost to Follow-up             28
Drug Screen             2
Administrative             3
Sponsor Decision             1
Multiple Reasons             1
Arm/Group Title ALO-01
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 465
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 465 participants
<=18 years
0
   0.0%
Between 18 and 65 years
417
  89.7%
>=65 years
48
  10.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 465 participants
51.7  (10.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 465 participants
Female
245
  52.7%
Male
220
  47.3%
Brief Pain Inventory (BPI) Average Pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on scale
Number Analyzed 465 participants
6.0  (1.67)
[1]
Measure Description: All patients reporting a BPI average pain score (over last 24 hours: 0=no pain, 10=worst pain) at baseline
1.Primary Outcome
Title Subjects With Treatment Emergent Adverse Events
Hide Description 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).
Time Frame up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients treated with study drug
Arm/Group Title ALO-01
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 465
Measure Type: Number
Unit of Measure: participants
378
2.Secondary Outcome
Title Mean Percent Change From Baseline to 12 Weeks in Brief Pain Inventory Score (BPI) of Average Pain
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data at Week 12
Arm/Group Title ALO-01
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 254
Mean (Standard Deviation)
Unit of Measure: Percent change
-31.3  (37.44)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALO-01
Comments Null hypothesis: Percent change from baseline = 0
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Mean Percent Change From Baseline to 52 Weeks in Brief Pain Inventory Score (BPI) of Average Pain
Hide Description 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.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with data at Week 52
Arm/Group Title ALO-01
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 162
Mean (Standard Deviation)
Unit of Measure: Percent change
-41.5  (39.28)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ALO-01
Comments Null hypothesis: Percent change from baseline = 0
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ALO-01
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
ALO-01
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
ALO-01
Affected / at Risk (%) # Events
Total   33/465 (7.10%)    
Cardiac disorders   
Acute myocardial infarction   1/465 (0.22%)  1
Angina pectoris   1/465 (0.22%)  1
Cardiac failure congestive   1/465 (0.22%)  1
Coronary artery disease   1/465 (0.22%)  1
Gastrointestinal disorders   
Colitis   2/465 (0.43%)  2
Diarrhoea   1/465 (0.22%)  1
Gastrointestinal inflammation   1/465 (0.22%)  1
Pancreatitis   1/465 (0.22%)  1
Vomiting   1/465 (0.22%)  1
General disorders   
Chest pain   2/465 (0.43%)  2
Pyrexia   1/465 (0.22%)  1
Hepatobiliary disorders   
Cholelithiasis   1/465 (0.22%)  1
Infections and infestations   
Arthritis bacterial   2/465 (0.43%)  2
Pyelonephritis acute   1/465 (0.22%)  1
Injury, poisoning and procedural complications   
Ankle fracture   1/465 (0.22%)  1
Overdose (insulin)   1/465 (0.22%)  1
Metabolism and nutrition disorders   
Diabetes mellitus inadequate control   1/465 (0.22%)  1
Hypoglycaemia   1/465 (0.22%)  1
Ketosis   1/465 (0.22%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia   1/465 (0.22%)  1
Invertebral disc protrusion   1/465 (0.22%)  1
Osteoarthritis   2/465 (0.43%)  2
Rheumatoid arthritis   1/465 (0.22%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer stage I   1/465 (0.22%)  1
Nervous system disorders   
Carotid artery stenosis   1/465 (0.22%)  1
Lumbar radiculopathy   1/465 (0.22%)  2
Transient ischaemic attack   1/465 (0.22%)  1
Psychiatric disorders   
Conversion disorder   1/465 (0.22%)  1
Somatoform disorder   1/465 (0.22%)  1
Suicidal ideation   1/465 (0.22%)  1
Surgical and medical procedures   
Appendicectomy   1/465 (0.22%)  1
Hip surgery   1/465 (0.22%)  1
Vascular disorders   
Deep vein thrombosis   2/465 (0.43%)  2
Peripheral vascular disorder   1/465 (0.22%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ALO-01
Affected / at Risk (%) # Events
Total   265/465 (56.99%)    
Gastrointestinal disorders   
Constipation   148/465 (31.83%) 
Nausea   117/465 (25.16%) 
Vomiting   54/465 (11.61%) 
Diarrhoea   35/465 (7.53%) 
General disorders   
Fatigue   29/465 (6.24%) 
Nervous system disorders   
Headache   56/465 (12.04%) 
Somnolence   36/465 (7.74%) 
Psychiatric disorders   
Insomnia   27/465 (5.81%) 
Skin and subcutaneous tissue disorders   
Pruritus   29/465 (6.24%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the Sponsor for review. Sponsor may request a delay in publication to allow the filing of patent applications before publication or release. The sponsor can require deletion of Confidential Information or request correction of inaccuracies.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President, Clinical Development
Organization: King Pharmaceuticals Research and Development, Inc.
Phone: 919-653-7001
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00415597    
Other Study ID Numbers: ALO-KNT-302
First Submitted: December 21, 2006
First Posted: December 25, 2006
Results First Submitted: September 11, 2009
Results First Posted: October 29, 2009
Last Update Posted: September 20, 2013