Chronic Non-Malignant PainPhase 3NCT00365898
Efficacy and Safety of Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain
A Phase 3 study testing Hydromorphone Hydrochloride Extended-Release in people with Chronic Non-Malignant Pain, run by Purdue Pharma LP at 14 sites in United States.
Trial summary
The objective of this study is to assess the efficacy and safety of 8 mg Hydromorphone Hydrochloride Extended-Release. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Non-Malignant Pain
- What is being tested?
- Hydromorphone Hydrochloride Extended-Release
- How many people
- 380 participants
- Where
- 14 sitesUnited States
- Study dates
- Jul 2005to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- persistent, moderate-to-severe noncancer related pain requiring continuous analgesia for weeks to months, or longer, who are currently taking 20 to 40 mg of oxycodone or opioid equivalents per day for control of their persistent pain and who are willing to accept the possibility of receiving placebo during the Double-Blind Phase
Who cannot join
- Patients already receiving opioid medication at an average total daily dose greater than 40 mg of oxycodone or opioid equivalents during the last week prior to study entry.
- Other protocol-specific exclusion/inclusion criteria may apply.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Allegheny Pain Management-PC 1402 Ninth Ave
Altoona, Pennsylvania, 16602
Hightop Medical Research Center 6103 Hamilton Anenue
Cincinnati, Ohio, 45224
Clinical Research of West Florida, Inc. 2147 NE Coachman Road
Clearwater, Florida, 33765
Research Institute of Greater Dayton 1010 Woodman Drive
Dayton, Ohio, 45432
LCFP, Inc. 12631 World Plaza Lane Building 54
Fort Myers, Florida, 33907
PharmQuest 301 E Wendover Avenue Suite 411
Greensboro, North Carolina, 27401
Pharmaceutical Research Associates 1395 N. Courtenay Pkwy
Merritt Island, Florida, 33161
Arizona Research Center 2525 W. Greenway Rd. Suite 114
Phoenix, Arizona, 85023
Stedman Clinical Trials 3212 Cove Bend Drive
Tampa, Florida, 33613
he Tipton Medical & Diagnostic Center #334 Route 220
Tipton, Pennsylvania, 16684
Preferred Primary Care Physicians 202 Jacob Murphy Lane
Uniontown, Pennsylvania, 15401
Palm Beach Research Center 1897 Palm Beach Lakes Blvd.
West Palm Beach, Florida, 33409
Gold Coast Research 2965 Surrey Lane
Weston, Florida, 33331
Pharmacotherapy Research Associates, Inc. 3620 Court Drive
Zanesville, Ohio, 43701
About this study
Official title: A Study of the Efficacy and Safety of 8 Mg Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain
The objective of this study is to assess the efficacy and safety of 8 mg Hydromorphone Hydrochloride Extended-Release.
Read the detailed description
The primary efficacy objective of this study is to compare the time to emergence of inadequate analgesia of 8 mg Hydromorphone Hydrochloride Extended-Release taken once every 24 hours versus placebo in the treatment of patients with persistent pain who require an opioid medication for control of their pain.
- Conditions
- Chronic Non-Malignant Pain
- Being tested
- Hydromorphone Hydrochloride Extended-Release
- Keywords
- Chronic non-malignant pain, opioid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromorphone Hydrochloride Extended-ReleaseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to emergence of inadequate analgesia. Emergence of inadequate analgesia is defined as one or more of the following: a) the subject has a rating of poor or fair on the Patient Global Assessment of Pain Medicatio
Secondary outcomes (2)
Patient Global Assessment of Pain Medication
Pain Control Questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2006 (estimated)
- Study startJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-Malignant 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
- Double blind
- Enrolment
- 380 participants
Sponsor and investigators
- Lead sponsor
- Purdue Pharma LP
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365898
- Sponsor's protocol ID
- HMP3011
- Status last verified
- Aug 2006
- First submitted
- 16 Aug 2006
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Efficacy and Safety of 8 Mg Hydromorphone Hydrochloride Extended-Release Compared to Placebo in Subjects With Persistent Pain
- ClinicalTrials.gov ID
- NCT00365898
- Acronym / sponsor ID
- HMP3011
- Conditions
- Chronic Non-Malignant Pain
- Keywords
- Chronic non-malignant pain, opioid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 380 participants
- Lead sponsor
- Purdue Pharma LPIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Jul 2005
- First posted
- 18 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the efficacy and safety of 8 mg Hydromorphone Hydrochloride Extended-Release.
Detailed description
The primary efficacy objective of this study is to compare the time to emergence of inadequate analgesia of 8 mg Hydromorphone Hydrochloride Extended-Release taken once every 24 hours versus placebo in the treatment of patients with persistent pain who require an opioid medication for control of their pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- persistent, moderate-to-severe noncancer related pain requiring continuous analgesia for weeks to months, or longer, who are currently taking 20 to 40 mg of oxycodone or opioid equivalents per day for control of their persistent pain and who are willing to accept the possibility of receiving placebo during the Double-Blind Phase
Key exclusion criteria (2 listed)
- Patients already receiving opioid medication at an average total daily dose greater than 40 mg of oxycodone or opioid equivalents during the last week prior to study entry.
- Other protocol-specific exclusion/inclusion criteria may apply.
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 |
|---|---|---|
| Hydromorphone Hydrochloride Extended-Release | Drug | – |
Primary outcome
Time to emergence of inadequate analgesia. Emergence of inadequate analgesia is defined as one or more of the following: a) the subject has a rating of poor or fair on the Patient Global Assessment of Pain Medicatio
2 secondary outcomes
Patient Global Assessment of Pain Medication
Pain Control Questionnaire
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
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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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydromorphone Hydrochloride Extended-Release in people with Chronic Non-Malignant Pain, run by Purdue Pharma LP at 14 sites in United States.
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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study was stopped early. Results are not available in the source record.
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?
Time to emergence of inadequate analgesia. Emergence of inadequate analgesia is defined as one or more of the following: a) the subject has a rating of poor or fair on the Patient Global Assessment of Pain Medicatio. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2006.