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

NCT00549042 | Completed Phase 3 Results

• 1 other identifier: NMT 1077-301
• Study Type: interventional
• Target: 459
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will test an experimental drug called OROS® hydromorphone hydrochloride (HCl) (NMED-1077), a once daily opioid analgesic that can relieve pain. A large number of clinical studies have been conducted to test this drug. OROS hydromorphone HCl is currently approved in both the US and Europe to treat chronic pain. The purpose of this study is to compare OROS hydromorphone to placebo to see if it is safe and efficacious.

Conditions

Chronic Low Back Pain

Keywords

Back Pain; Chronic Low Back Pain; Chronic Back Pain; Pain; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 12 in Mean Pain Intensity

  Participants rate their pain intensity on a numeric rating scale (NRS), where 0=no pain and 10=worst possible pain, in a daily diary. At Week 12 (or final visit), all measurements during the preceding week are averaged, and the mean change from the mean score at baseline is calculated.

  Baseline, Week 12 (or final visit)

Other Outcomes (5)

• Change From Baseline in Mean Pain Intensity Scores Through the Entire 12-week Treatment Phase

  Baseline through Week 12

• Change From Baseline in Mean Patient Global Assessment (PGA) Scores

  Baseline through Week 12

• Change From Baseline in Mean Scores on the Roland-Morris Disability Questionnaire

  Baseline through Week 12

Study Arms (2)

OROS hydromorphone

EXPERIMENTAL

OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg

Drug: OROS hydromorphone

placebo

PLACEBO COMPARATOR

Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).

Drug: Placebo

Interventions

OROS hydromorphone DRUG

hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets

OROS hydromorphone

Placebo DRUG

Placebo

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Male and female patients aged 18-75 years, inclusive.
• Documented diagnosis of moderate to severe chronic low back pain that must have been present
• Patients who are classified as non-neuropathic (Class 1 and 2) or neuropathic (Class 3, 4, 5 and 6) of lower back pain based on the Quebec Task Force Classification of Spinal Disorders will be enrolled for this study.
• Patients who require daily scheduled opioid analgesics for low back pain for at least 2 months prior to the screening visit.
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• Patients who have undergone a surgical procedure for back pain within 6 months prior to the screening visit.
• Patients who have had nerve or plexus block, including epidural steroid injections or facet blocks, within 1 month prior to the screening visit.
• 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).
• Patients who are involved in an active workman's compensation or insurance claim or disability claim or litigation related to back pain.
• 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.
• Patients who have abused prescription medication or alcohol within 5 years prior to the screening visit.
• Patients with a positive alcohol or drugs of abuse test
• 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.
• Patients who have demonstrated allergic reactions or hypersensitivity to opioids.
• Patients who have had no bowel movement within three days, or bowel obstruction within 60 days, prior to the screening visit.
• Patients with pre-existing severe narrowing of the gastrointestinal tract secondary to:
• prior gastrointestinal surgery (e.g., vagotomy, antrectomy, pyloroplasty, 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 pseudoobstruction, or Meckel diverticulum)
• Patients who have a major psychiatric condition (e.g., schizophrenia, major depression) or who have clinically significant anxiety or depression as defined by a Hospital Anxiety and Depression Scale(HADS) score greater than 10.
• Patients who have received monoamine oxidase (MAO) inhibitors within 14 days prior to the screening visit.

Sponsors & Collaborators

• Mallinckrodt: lead

Related Publications (2)

• Nalamachu S, Hale M, Khan A. Hydromorphone extended release for neuropathic and non-neuropathic/nociceptive chronic low back pain: a post hoc analysis of data from a randomized, multicenter, double-blind, placebo-controlled clinical trial. J Opioid Manag. 2014 Sep-Oct;10(5):311-22. doi: 10.5055/jom.2014.0221.

  PMID: 25350473 DERIVED

• Hale M, Khan A, Kutch M, Li S. Once-daily OROS hydromorphone ER compared with placebo in opioid-tolerant patients with chronic low back pain. Curr Med Res Opin. 2010 Jun;26(6):1505-18. doi: 10.1185/03007995.2010.484723.

  PMID: 20429852 DERIVED

MeSH Terms

Conditions

Back Pain; Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alfredo Bozzini, MD
• Organization: Covidien

Alfredo.Bozzini@covidien.com

314-654-2000

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2007
• First Posted: October 25, 2007
• Study Start: October 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: June 17, 2020
• Results First Posted: June 17, 2020

Record last verified: 2019-02