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

A Phase 3 study testing OROS hydromorphone in people with Chronic Low Back Pain, run by Mallinckrodt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Chronic Low Back Pain
What is being tested?: OROS hydromorphone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 459 participants
Where: No sites listed yet
Study dates: Oct 2007to Jan 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.
Patients with clinically significant abnormal laboratory results in clinical chemistry, hematology or urinalysis 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.
Patients with a serious or unstable intercurrent illness.
Patients with a history of uncontrolled seizure disorder.
Patients with increased intracranial pressure, mental clouding of unknown etiology, coma, or hypotension.
Patients who have severe asthma, severe chronic obstructive pulmonary disease, or any other disorder that predisposes the patient to carbon dioxide retention or respiratory depression.
Patients who have taken any investigational drug within 30 days prior to the screening visit or are currently enrolled in another investigational drug study.

About this study

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

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
Being tested: OROS hydromorphone, Placebo
Keywords: Back Pain, Chronic Low Back Pain, Chronic Back Pain, Pain, Chronic Pain
Medical subject headings: Back Pain, Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OROS hydromorphoneDrug
hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets
PlaceboDrug
Placebo

Study groups in NCT00549042
Study group	Role	What they receive
OROS hydromorphone	Experimental	OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg Receives: 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). Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, Week 12 (or final visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Jan 2009

First posted25 Oct 2007 (estimated)
Study startOct 2007
Primary completionJan 2009
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 459 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00549042
Sponsor's protocol ID: NMT 1077-301
Status last verified: Feb 2019
First submitted: 23 Oct 2007
Last updated: 17 Jun 2020
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 25350473
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.
PubMed 20429852

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
A Novel Treatment for Chronic Low Back Pain Using Multi Angular Isometric Lumbar Exercise: Randomized Clinical Trial.
Nonspecific Low Back Pain, Low Back Pain
Recruiting
Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
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Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
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All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00549042
Acronym / sponsor ID: NMT 1077-301
Conditions: Chronic Low Back Pain
Keywords: Back Pain, Chronic Low Back Pain, Chronic Back Pain, Pain, Chronic Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 459 participants (actual)
Lead sponsor: MallinckrodtIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 25 Oct 2007 (estimated)
Results: Posted 17 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare OROS hydromorphone to placebo to see if it is safe and efficacious.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
OROS hydromorphone	Experimental	Drug: OROS hydromorphoneOROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg
placebo	Placebo comparator	Drug: PlaceboMatching 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).

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (21 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OROS hydromorphonehydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets	Drug	OROS hydromorphone
PlaceboPlacebo	Drug	placebo

Primary outcome

Change From Baseline to Week 12 in Mean Pain Intensity
Time frame: Baseline, Week 12 (or final visit)
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.

Results and safety

Results posted to the registry on 17 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
OROS Hydromorphone	459	268
Placebo	0	0

Primary outcome: Change From Baseline to Week 12 in Mean Pain Intensity

Time frame: Baseline, Week 12 (or final visit). Mean (Full Range). Unit: score on a scale

Measure	OROS Hydromorphone n = 133	Placebo n = 133
Value	0.6 (-5 to 5)	1.7 (-3 to 7)

Population analysed: Intent-to-treat population (ITT). One patient (randomized to receive OROS hydromorphone) did not report taking any study medication, and another (randomized to receive placebo) did not have Baseline values for the primary efficacy variable; both were excluded from the ITT population. Therefore, the ITT population had 266 patients.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Conversion and Titration Phase	5 of 447 (1.1%)	247 of 447 (55.3%)	Not reported
OROS Hydromorphone	6 of 134 (4.5%)	64 of 134 (47.8%)	Not reported
Placebo	4 of 134 (3%)	73 of 134 (54.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25350473Nalamachu 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.
Derived from this study: PubMed 20429852Hale 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.

Related trials for Chronic Low Back Pain

Recruiting
A Novel Treatment for Chronic Low Back Pain Using Multi Angular Isometric Lumbar Exercise: Randomized Clinical Trial.
Nonspecific Low Back Pain, Low Back Pain
Recruiting
Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
Chronic Low-back Pain, Chronic Pain
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OROS hydromorphone in people with Chronic Low Back Pain, run by Mallinckrodt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to Week 12 in Mean Pain Intensity (time frame: Baseline, Week 12 (or final visit)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00549042, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.