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Lumbar Stenosis Outcomes Research II (LUSTORII)

This study has been terminated.
(Removal of Darvocet from US market)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00652093
First Posted: April 3, 2008
Last Update Posted: March 25, 2016
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.
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
John Markman, University of Rochester
Results First Submitted: July 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Lumbar Spinal Stenosis
Interventions: Drug: opana then darvocet then placebo
Drug: opana then placebo then darvocet
Drug: placebo then opana then darvocet
Drug: Placebo then darvocet then opana
Drug: Darvocet then opana then placebo
Drug: Darvocet then placebo then opana

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

08 December 2007 (initial IRB approval) to 26 August 2011* (final study results) First patient enrolled: 12 June 2008. Last patient completed: 12 October 2010

*Study terminated on 29 November 2010 due to US Food and Drug Administration (FDA) removing active control (Darvocet) from the U.S. market.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Forty-three subjects signed the Research Subject Review Board (local IRB) approved consent form. Nineteen subjects failed screening and did not meet inclusion criteria. Twenty-four subjects met radiographic and treadmill criteria for neurogenic claudication and were randomized. Of these, 21 subjects completed all phases of the study

Reporting Groups
  Description
Opana Then Darvocet Then Placebo Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
Opana Then Placebo Then Darvocet Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
Placebo Then Opana Then Darvocet Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
Placebo Then Darvocet Then Opana Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
Darvocet Then Opana Then Placebo Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
Darvocet Then Placebo Then Opana Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.

Participant Flow:   Overall Study
    Opana Then Darvocet Then Placebo   Opana Then Placebo Then Darvocet   Placebo Then Opana Then Darvocet   Placebo Then Darvocet Then Opana   Darvocet Then Opana Then Placebo   Darvocet Then Placebo Then Opana
STARTED   4   4   4   4   4   4 
COMPLETED   4   4   3   4   2   4 
NOT COMPLETED   0   0   1   0   2   0 
Withdrawal by Subject                0                0                1                0                1                0 
Physician Decision                0                0                0                0                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Opana Then Darvocet Then Placebo Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
Opana Then Placebo Then Darvocet Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
Placebo Then Opana Then Darvocet Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
Placebo Then Darvocet Then Opana Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
Darvocet Then Opana Then Placebo Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
Darvocet Then Placebo Then Opana Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
Total Total of all reporting groups

Baseline Measures
   Opana Then Darvocet Then Placebo   Opana Then Placebo Then Darvocet   Placebo Then Opana Then Darvocet   Placebo Then Darvocet Then Opana   Darvocet Then Opana Then Placebo   Darvocet Then Placebo Then Opana   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   4   4   4   4   4   24 
Age 
[Units: Participants]
             
<=18 years   0   0   0   0   0   0   0 
Between 18 and 65 years   0   0   1   0   1   2   4 
>=65 years   4   4   3   4   3   2   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.5  (4)   73.0  (3.2)   76.0  (12)   70.0  (4.8)   76.0  (15.2)   63.3  (6.8)   71.3  (9.0) 
Gender 
[Units: Participants]
             
Female   0   1   3   3   3   2   12 
Male   4   3   1   1   1   2   12 
Region of Enrollment 
[Units: Participants]
             
United States   4   4   4   4   4   4   24 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to First Symptoms (Tfirst) of Moderate Pain   [ Time Frame: study visit ]

2.  Secondary:   Area Under the Curve   [ Time Frame: study visit ]

3.  Secondary:   Total Distance   [ Time Frame: study visit ]

4.  Secondary:   Recovery Time   [ Time Frame: study visit ]

5.  Secondary:   Visual Analog Scale (VAS)   [ Time Frame: study visit ]

6.  Secondary:   Patient Global Assessment (PGA)   [ Time Frame: study visit ]

7.  Secondary:   Roland Morris Disability Questionnaire (RMDQ)   [ Time Frame: study visit ]

8.  Secondary:   Modified Brief Pain Inventory (mBPI)- Interference Score   [ Time Frame: study visit ]

9.  Secondary:   Oswestry Disability Index (ODI) Score   [ Time Frame: study visit ]

10.  Secondary:   Swiss Spinal Stenosis Score- Symptom Severity   [ Time Frame: study visit ]

11.  Secondary:   Swiss Spinal Stenosis Score- Physical Function   [ Time Frame: study visit ]

12.  Secondary:   Final Pain   [ Time Frame: study visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This study terminated early (leading to small number of subjects analyzed) due to US Food and Drug Administration (FDA) removing active control (Darvocet) from the U.S. market.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. John D. Markman, MD
Organization: Translational Pain Research, University of Rochester Medical Center
phone: 585-276-3616
e-mail: john_markman@urmc.rochester.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: John Markman, University of Rochester
ClinicalTrials.gov Identifier: NCT00652093     History of Changes
Other Study ID Numbers: 20957
First Submitted: March 11, 2008
First Posted: April 3, 2008
Results First Submitted: July 10, 2012
Results First Posted: March 25, 2016
Last Update Posted: March 25, 2016