Lumbar Stenosis Outcomes Research II

NCT00652093 | Terminated Phase 4 Results DMC

• 1 other identifier: 20957
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone hydrochloride and propoxyphene/acetaminophen combination in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients lumbar spinal stenosis that have clinical symptoms of neurogenic claudication. Neurogenic claudication is defined as movement induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or both legs provoked with walking and standing and relieved by sitting, squatting, or forward flexion posturing. The secondary objective is to examine the functional benefit of oxymorphone hydrochloride and propoxyphene/acetaminophen combination with respect to improvement in duration and distance of walking.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Time to First Symptoms (Tfirst) of Moderate Pain

  Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured. Patients were excluded from the trial if there pain at rest was greater than or equal to 4/10.

  study visit

Secondary Outcomes (11)

• Area Under the Curve

  study visit

• Total Distance

  study visit

• Recovery Time

  study visit

• Visual Analog Scale (VAS)

  study visit

• Patient Global Assessment (PGA)

  study visit

Study Arms (6)

Opana then darvocet then placebo

EXPERIMENTAL

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.

Drug: opana then darvocet then placebo

Opana then placebo then darvocet

EXPERIMENTAL

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.

Drug: opana then placebo then darvocet

Placebo then opana then darvocet

EXPERIMENTAL

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.

Drug: placebo then opana then darvocet

Placebo then darvocet then opana

EXPERIMENTAL

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.

Drug: Placebo then darvocet then opana

Darvocet then opana then placebo

EXPERIMENTAL

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.

Drug: Darvocet then opana then placebo

Darvocet then placebo then opana

EXPERIMENTAL

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.

Drug: Darvocet then placebo then opana

Interventions

opana then darvocet then placebo DRUG

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.

Also known as: opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug

Opana then darvocet then placebo

opana then placebo then darvocet DRUG

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.

Also known as: opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug

Opana then placebo then darvocet

placebo then opana then darvocet DRUG

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.

Also known as: opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug

Placebo then opana then darvocet

Placebo then darvocet then opana DRUG

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.

Also known as: opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug

Placebo then darvocet then opana

Darvocet then opana then placebo DRUG

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.

Also known as: opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug

Darvocet then opana then placebo

Darvocet then placebo then opana DRUG

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.

Also known as: opana: oxymorphone HCL, darvocet: propoxyphene/acetaminophen, placebo: inactive drug

Darvocet then placebo then opana

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must present with clinical symptoms of neurogenic claudication (exercise induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or both legs provoked with walking and standing and relieved by sitting, squatting, or forward flexion posturing) and endorse limitation of walking tolerance due to these symptoms
• Numeric Rating Scale (NRS) for pain ≥ 6 in response to the following question: "Circle one number (from 0=no pain to 10=worst pain) - How would you rate the worst leg and lower back pain you experienced during walking last week?"
• Patients must have confirmatory imaging by MRI or CT scan demonstrating at least one level of lumbar spinal stenosis within 1 year
• Duration of symptoms \> 3 months
• Age \> 50 years; male or female

You may not qualify if:

• Past or present existence of a movement disorder, e.g., Parkinsonism, or an neurologic disease that might affect the ability to ambulate (e.g., signs/symptoms of cauda equina compression)
• Cognitive impairment preventing full understanding or participation in the study
• Peripheral vascular disease
• Moderate to severe arthritis of the knee or hip that might severely compromise ambulation
• Past or present lower extremity peripheral vascular disease
• Serious concomitant medical illness (e.g., heart disease) that might impair ambulation assessment
• Previous lumbar surgery for spinal stenosis (laminectomy with or without fusion) within the past 2 years or epidural steroid injection in the preceding 4 months.
• Severe psychiatric disorder
• Mean time to severe symptoms \> 15 minutes.
• Epidural steroid treatment within the last three months
• History of drug or alcohol dependence
• Serious intercurrent illness
• Hypersensitivity to oxymorphone hydrochloride
• Hypersensitivity to propoxyphene or acetaminophen
• Severe bronchial asthma or hypercarbia, morphine analogs such as codeine, or any of the other ingredients of Opana

Sponsors & Collaborators

• University of Rochester: lead
• Endo Pharmaceuticals: collaborator

Study Sites (1)

2180 S. Clinton Ave

Rochester, New York, 14618, United States

Location

Related Publications (6)

• Simon LS, Evans C, Katz N, Bombardier C, West C, Robbins J, Copley-Merriman C, Markman J, Coombs JH. Preliminary development of a responder index for chronic low back pain. J Rheumatol. 2007 Jun;34(6):1386-91.

  PMID: 17552065 BACKGROUND

• Markman JD, Dworkin RH. Ion channel targets and treatment efficacy in neuropathic pain. J Pain. 2006 Jan;7(1 Suppl 1):S38-47. doi: 10.1016/j.jpain.2005.09.008.

  PMID: 16427000 BACKGROUND

• Deen HG Jr, Zimmerman RS, Lyons MK, McPhee MC, Verheijde JL, Lemens SM. Test-retest reproducibility of the exercise treadmill examination in lumbar spinal stenosis. Mayo Clin Proc. 2000 Oct;75(10):1002-7. doi: 10.4065/75.10.1002.

  PMID: 11040847 BACKGROUND

• Deen HG, Zimmerman RS, Lyons MK, McPhee MC, Verheijde JL, Lemens SM. Use of the exercise treadmill to measure baseline functional status and surgical outcome in patients with severe lumbar spinal stenosis. Spine (Phila Pa 1976). 1998 Jan 15;23(2):244-8. doi: 10.1097/00007632-199801150-00019.

  PMID: 9474733 BACKGROUND

• Stucki G, Daltroy L, Liang MH, Lipson SJ, Fossel AH, Katz JN. Measurement properties of a self-administered outcome measure in lumbar spinal stenosis. Spine (Phila Pa 1976). 1996 Apr 1;21(7):796-803. doi: 10.1097/00007632-199604010-00004.

  PMID: 8779009 BACKGROUND

• Markman JD, Gewandter JS, Frazer ME, Murray NM, Rast SA, McDermott MP, Chowdhry AK, Tomkinson EJ, Pilcher WH, Walter KA, Dworkin RH. A Randomized, Double-blind, Placebo-Controlled Crossover Trial of Oxymorphone Hydrochloride and Propoxyphene/Acetaminophen Combination for the Treatment of Neurogenic Claudication Associated With Lumbar Spinal Stenosis. Spine (Phila Pa 1976). 2015 May 15;40(10):684-91. doi: 10.1097/BRS.0000000000000837.

  PMID: 25705958 DERIVED

MeSH Terms

Conditions

Spinal Stenosis

Interventions

Oxymorphone; Acetaminophen

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

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; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. John D. Markman, MD
• Organization: Translational Pain Research, University of Rochester Medical Center

john_markman@urmc.rochester.edu

585-276-3616

Study Officials

• John D Markman, M.D.

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Translational Pain Research

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: April 3, 2008
• Study Start: March 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: August 1, 2011
• Last Updated: March 25, 2016
• Results First Posted: March 25, 2016

Record last verified: 2016-02

Locations

US (1)