Study to Test the Effectiveness of Controlled-Release OROS® Hydromorphone HCl Compared to Placebo in Patients With Chronic Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT00549042
First received: October 23, 2007
Last updated: March 20, 2012
Last verified: March 2012
  Purpose

This study will test an experimental drug called OROS® hydromorphone hydrochloride (HCl), a once daily opioid analgesic that can relieve pain. A large number of clinical studies have been conducted to test this drug. NMED-1077 is still being tested and is not approved by the Food and Drug Administration (FDA) for sale in the United States. OROS® hydromorphone HCl is currently approved in Europe to treat chronic pain.

The purpose of this study is to compare NMED-1077 to placebo to see if NMED-1077 is safe and efficacious.


Condition Intervention Phase
Chronic Low Back Pain
Drug: Drug: OROS® hydromorphone at 4, 8, 16, and 32 mg tablets will be used to provide doses of 12-64mg.
Drug: Oros Hydromorphone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Variable-Dose Titration Followed by a Randomized Double-Blind Study of Controlled-Release OROS® Hydromorphone HCl (NMED-1077) Compared to Placebo in Patients With Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by Mallinckrodt:

Primary Outcome Measures:
  • The primary efficacy variable is the mean change from baseline to week 12 (or last visit) average pain intensity of double-blind treatment phase based on the weekly pain intensity scores obtained from patient diary entry, as compared to placebo. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Additional analyses on pain intensity. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 266
Study Start Date: September 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oros Hydromorphone Drug: Drug: OROS® hydromorphone at 4, 8, 16, and 32 mg tablets will be used to provide doses of 12-64mg.
hydromorphone 4, 8, 16, and 32 mg tablets
Drug: Oros Hydromorphone
Oros Hydromorphone
Placebo Comparator: placebo Drug: Drug: OROS® hydromorphone at 4, 8, 16, and 32 mg tablets will be used to provide doses of 12-64mg.
hydromorphone 4, 8, 16, and 32 mg tablets
Drug: Oros Hydromorphone
Oros Hydromorphone

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  1. Patients must have been provided with written consent to participate in the study prior to any study procedures, and must understand that they are free to withdraw from the study at any time.
  2. Patients who can speak, read, write, and understand English, and must be able to read and understand the consent form, complete study-related procedures, and communicate with the study staff.
  3. Male and female patients aged 18-75 years, inclusive.
  4. Documented diagnosis of moderate to severe chronic low back pain that must have been present
  5. Patients who are classified as non-neuropathic (Class 1 and 2) or neuropathic (Class 3, 4, 5 and 6) of LBP based on the Quebec Task Force Classification of Spinal Disorders will be enrolled for this study.
  6. Patients who require daily scheduled opioid analgesics for low back pain for at least 2 months prior to the screening visit.
  7. Patients with a daily opioid requirement of ≥ 60 mg oral morphine equivalent (≥ 12 mg hydromorphone), but ≤ 320 mg morphine (≤ 64 mg hydromorphone) per day within the 2 months prior to the screening visit.
  8. Patients who, in the Investigator's opinion, are on a stable dose (≥ 2 weeks) of all prior analgesics (both opioid and non-opioid) prior to the screening visit.
  9. Female subjects of childbearing potential including those who have had a tubal ligation surgery but excluding those who have not experienced a menstrual period for a minimum of 2 years, must have a negative serum pregnancy test at screening visit, and must consent to utilize a medically acceptable method of contraception throughout the entire study period including the washout period and for 1 week after the study is completed.

EXCLUSION CRITERIA

  1. Patients with an active diagnosis of fibromyalgia, complex regional pain syndrome (including reflex sympathetic dystrophy or causalgia), acute spinal cord compression, severe or progressive lower extremity weakness or numbness, bowel or bladder dysfunction as a result of cauda equina compression, diabetic amyotrophy, meningitis, diskitis, back pain because of secondary infection or tumor, or pain caused by a confirmed or suspected neoplasm.
  2. Patients who have undergone a surgical procedure for back pain within 6 months prior to the screening visit.
  3. Patients who have had nerve or plexus block, including epidural steroid injections or facet blocks, within 1 month prior to the screening visit.
  4. Patients with any other chronic pain condition that, in the investigator's opinion, would interfere with the assessment of low back pain (e.g., osteoarthritis, rheumatoid arthritis, postherpetic neuralgia, pain associated with diabetic neuropathy, migraine headaches requiring opioid therapy).
  5. Patients who are involved in an active workman's compensation or insurance claim or disability claim or litigation related to back pain.
  6. Patients who have by history used any illicit drugs of abuse, abused opioids or exhibited drug seeking behavior within 5 years prior to the screening visit.
  7. Patients who have abused prescription medication or alcohol within 5 years prior to the screening visit. (See appendix 11 for the DSM-IV criteria for substance abuse.)
  8. Patients with a positive alcohol or drugs of abuse test
  9. Women who are pregnant (as indicated by a positive result in a serum pregnancy test administered at screening visit), or breast feeding, or planning to breast feed within 30 days prior to the screening visit.
  10. Patients who have demonstrated allergic reactions or hypersensitivity to opioids.
  11. Patients who have had no bowel movement within three days, or bowel obstruction within 60 days, prior to the screening visit.
  12. Patients with pre-existing severe narrowing of the gastrointestinal tract secondary to:

    prior gastrointestinal surgery (e.g., vagotomy, antrectomy, pyroloplasty, gastroplasty, gastrojejunostomy) or gastrointestinal disease resulting in impaired gastrointestinal function (e.g., paralytic ileus, gastroparesis, inflammatory bowel disease, "short gut" syndrome due to adhesions or decreased transit time, past history of peritonitis, cystic fibrosis, chronic intestinal pseudobstruction, or Meckel diverticulum)

  13. Patients who have a major psychiatric condition (e.g., schizophrenia, major depression) or who have clinically significant anxiety or depression as defined by a HADS score greater than 10.
  14. Patients who have received monoamine oxidase (MAO) inhibitors within 14 days prior to the screening visit.
  15. Patients with clinically significant abnormal laboratory results in clinical chemistry, hematology or urinalysis as defined by Appendix 9, including serum glutamic-oxaloacetic transaminase/aspartate aminotransferase (AST) or serum glutamic-pyruvic transaminase/alanine aminotransferase (ALT) ≥ 3.0 times the upper limit of the reference range or a serum creatinine ≥ 2.0 mg/dL at screening.
  16. Patients with a serious or unstable intercurrent illness.
  17. Patients with a history of uncontrolled seizure disorder.
  18. Patients with increased intracranial pressure, mental clouding of unknown etiology, coma, or hypotension.
  19. Patients who have severe asthma, severe chronic obstructive pulmonary disease, or any other disorder that predisposes the patient to CO2 retention or respiratory depression.
  20. Patients who have taken any investigational drug within 30 days prior to the screening visit or are currently enrolled in another investigational drug study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by Mallinckrodt

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT00549042     History of Changes
Other Study ID Numbers: NMT 1077-301
Study First Received: October 23, 2007
Last Updated: March 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Mallinckrodt:
Back Pain
Chronic Low Back Pain
Chronic Back Pain
Pain
Chronic Pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Hydromorphone
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on July 22, 2014