PainPhase 3NCT00980798
Placebo-controlled Trial With OROS Hydromorphone Hydrochloride to Treat Patients With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee
A Phase 3 study testing OROS hydromorphone HCl in people with Pain and Osteoarthritis, Hip, run by Janssen-Cilag International NV at 12 sites in 4 countries.
Trial summary
This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who are suffering from pain due to osteoarthritis of the hip or the knee and who previously did not receive any strong opioids.The clinical trial tests the effect… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
- What is being tested?
- OROS hydromorphone HCl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 288 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Oct 2007to Nov 2008
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented Osteoarthritis of the hip or knee
- Chronic pain for more than 3 months treated with daily analgesic for the last month
- Moderate to severe OA pain of the target joint, which cannot be adequately treated with non-steroidal anti-inflamatory drugs or paracetamol
- Moderate to severe pain by means of a mean weekly score of >= 5 in the Brief Pain Invetory item 5 'pain on average'
Who cannot join
- Regular treatment with an opioid in the 4 weeks before screening visit (infrequent use of tramadol, codeine, tilidine, or dihydrocodeine for no more than 10 days in the 4 weeks before the screening visit is acceptable, however, treatment must be stopped at screening visit)
- Diagnosis of major depression
- Treatment for epilepsy
- Corticosteroid injection within the last 3 months
- Major surgery in the 3 months before the start of the study
- Women who are pregnant or breast-feeding
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Czechia5 sites
Study site
Klatovy
Study site
Olomouc
Study site
Pelhøimov
Study site
Prague
Study site
Roudnice nad Labem
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Investigate the Analgesic Effect of OROS Hydromorphone Hydrochloride in Comparison With Placebo in Subjects With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee
This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who are suffering from pain due to osteoarthritis of the hip or the knee and who previously did not receive any strong opioids.The clinical trial tests the effect of the treatment on symptoms of pain, stiffness and physical function. The effect of the treatment on parameters on health related quality of life as well as quality of sleep will be measured.
Read the detailed description
In this clinical trial subjects are enrolled, who are suffering from pain due to osteoarthritis of the hip or the knee that is not sufficiently controlled with either a non steroidal anti-inflammatory drug (NSAID) or paracetamol or a weak opioid. This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who previously did not receive any strong opioids. The drug class of opioid analgesics can broadly be classified into strong and weak. Weak opioids (for example tramadol, codeine, dihydrocodeine and tilidine) are useful for mild to moderate pain and the strong opioids (for example morphine, fentanyl and hydromorphone) are useful for moderate to severe pain of different origin. OROS hydromorphone is an opioid, which is available in a prolonged-release tablet in different dosage strengths. The primary aim of the study is to test the efficacy of OROS hydromorphone against placebo at an individual dose sufficient to control the pain and to establish the usefulness of a new low-dose formulation of OROS hydromorphone (4 mg hydromorphone per tablet) for initiating the treatment and for dose titration. The clinical trial tests the effect of the treatment on symptoms of pain, stiffness and physical function. The effect of the treatment on parameters on health related quality of life as well as quality of sleep will be measured. The safety of the treatment will be recorded by measuring blood pressure, heart rate, and respiratory rate.This clinical trial is a placebo-controlled trial, meaning that one group of patients will receive the drug to be tested (OROS hydromorphone) while the control group receives an optically identical tablet with no active ingredient, a so-called placebo. A total number of 270 patients will be enrolled in this clinical trial and assigned to one of two treatment arms at an equal ratio (i.e. 135 patients per treatment). Patients will be randomly assigned to one of the two treatment arms, like flipping a coin to decide which treatment they will receive. Neither the patient nor the doctor will know to which of the two treatment arms the patient is assigned to and neither the patient nor the doctor can influence the assignment to the treatment arm. During the whole treatment period paracetamol will be allowed to be taken as needed in case of pain. Medical history and physical exam will be conducted during the screening visit, followed in 1 week by the baseline visit where after completing several questionnaires assessing pain, physical functioning quality of life and sleep quality, the patient will be assigned to one of two treatment groups. After starting the study treatment the patient will visit the doctor 7 times: at week 1, 2, 3, 4, 8, 12, 16 and at a follow-up visit after the end of the treatment period at week 16. At week 16 questionnaires will again be completed and the results will be compared to the baseline findings. 4, 8, 12, 16, 24 or 32 mg of OROS hydromorphone tablets or matching placebo tablets taken for 16 weeks. All tablets are taken by mouth at the same time each day in the morning. Tablets have to be swallowed whole without chewing or crushing. After completion of the treatment duration (or at early withdrawal), the study medication is gradually tapered down over a maximum of 6 days.
- Conditions
- Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
- Being tested
- OROS hydromorphone HCl, Placebo
- Keywords
- Osteoarthritis, Strong pain killer, Strong opioid, Low starting dose, Fewer side effects, Physical functioning, Pain control, Quality of life, Sleep quality
- Medical subject headings
- Pain, Osteoarthritis, Hip, Osteoarthritis, Knee, Osteoarthritis, Agnosia, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OROS hydromorphone HClDrug
4 to 32 mg taken orally once daily for 16 weeks
PlaceboDrug
placebo tablet once daily for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | OROS hydromorphone HCl 4 to 32 mg taken orally once daily for 16 weeks Receives: Drug: OROS hydromorphone HCl |
| 002 | Placebo comparator | Placebo placebo tablet once daily for 16 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average)
The analgesic effect was assessed by the BPI item 5 "pain on average" using a 0 to 10 numeric rating scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine".
Measured: At each study visit from screening to week 16
Secondary outcomes (1)
The Number of Patients Discontinuing From the Trial Due to the Occurrence of an Adverse Event
The number of patients dropping out of the study owing to adverse events will be presented for each treatment group.
Measured: At each study visit from baseline until week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startOct 2007
- Primary completionNov 2008
- Study completionNov 2008
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.
- Other trials for 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
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980798
- Sponsor's protocol ID
- CR012601
- Other IDs
- HOP Trial
- Status last verified
- Apr 2014
- First submitted
- 18 Sep 2009
- Last updated
- 25 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Investigate the Analgesic Effect of OROS Hydromorphone Hydrochloride in Comparison With Placebo in Subjects With Moderate to Severe Pain Induced by Osteoarthritis of the Hip or the Knee
- ClinicalTrials.gov ID
- NCT00980798
- Acronym / sponsor ID
- CR012601
- Conditions
- Pain, Osteoarthritis, Hip, Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Strong pain killer, Strong opioid, Low starting dose, Fewer side effects, Physical functioning, Pain control, Quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 21 Sep 2009 (estimated)
- Results
- Posted 6 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who are suffering from pain due to osteoarthritis of the hip or the knee and who previously did not receive any strong opioids.The clinical trial tests the effect of the treatment on symptoms of pain, stiffness and physical function. The effect of the treatment on parameters on health related quality of life as well as quality of sleep will be measured.
Detailed description
In this clinical trial subjects are enrolled, who are suffering from pain due to osteoarthritis of the hip or the knee that is not sufficiently controlled with either a non steroidal anti-inflammatory drug (NSAID) or paracetamol or a weak opioid. This clinical trial tests the pain relieving effectiveness of OROS hydromorphone, a once-daily formulation of a strong opioid against placebo in patients, who previously did not receive any strong opioids. The drug class of opioid analgesics can broadly be classified into strong and weak. Weak opioids (for example tramadol, codeine, dihydrocodeine and tilidine) are useful for mild to moderate pain and the strong opioids (for example morphine, fentanyl and hydromorphone) are useful for moderate to severe pain of different origin. OROS hydromorphone is an opioid, which is available in a prolonged-release tablet in different dosage strengths. The primary aim of the study is to test the efficacy of OROS hydromorphone against placebo at an individual dose sufficient to control the pain and to establish the usefulness of a new low-dose formulation of OROS hydromorphone (4 mg hydromorphone per tablet) for initiating the treatment and for dose titration. The clinical trial tests the effect of the treatment on symptoms of pain, stiffness and physical function. The effect of the treatment on parameters on health related quality of life as well as quality of sleep will be measured. The safety of the treatment will be recorded by measuring blood pressure, heart rate, and respiratory rate.This clinical trial is a placebo-controlled trial, meaning that one group of patients will receive the drug to be tested (OROS hydromorphone) while the control group receives an optically identical tablet with no active ingredient, a so-called placebo. A total number of 270 patients will be enrolled in this clinical trial and assigned to one of two treatment arms at an equal ratio (i.e. 135 patients per treatment). Patients will be randomly assigned to one of the two treatment arms, like flipping a coin to decide which treatment they will receive. Neither the patient nor the doctor will know to which of the two treatment arms the patient is assigned to and neither the patient nor the doctor can influence the assignment to the treatment arm. During the whole treatment period paracetamol will be allowed to be taken as needed in case of pain. Medical history and physical exam will be conducted during the screening visit, followed in 1 week by the baseline visit where after completing several questionnaires assessing pain, physical functioning quality of life and sleep quality, the patient will be assigned to one of two treatment groups. After starting the study treatment the patient will visit the doctor 7 times: at week 1, 2, 3, 4, 8, 12, 16 and at a follow-up visit after the end of the treatment period at week 16. At week 16 questionnaires will again be completed and the results will be compared to the baseline findings. 4, 8, 12, 16, 24 or 32 mg of OROS hydromorphone tablets or matching placebo tablets taken for 16 weeks. All tablets are taken by mouth at the same time each day in the morning. Tablets have to be swallowed whole without chewing or crushing. After completion of the treatment duration (or at early withdrawal), the study medication is gradually tapered down over a maximum of 6 days.
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 |
|---|---|---|
| 001 | Experimental | Drug: OROS hydromorphone HClOROS hydromorphone HCl 4 to 32 mg taken orally once daily for 16 weeks |
| 002 | Placebo comparator | Drug: PlaceboPlacebo placebo tablet once daily for 16 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented Osteoarthritis of the hip or knee
- Chronic pain for more than 3 months treated with daily analgesic for the last month
- Moderate to severe OA pain of the target joint, which cannot be adequately treated with non-steroidal anti-inflamatory drugs or paracetamol
- Moderate to severe pain by means of a mean weekly score of >= 5 in the Brief Pain Invetory item 5 'pain on average'
Key exclusion criteria (6 listed)
- Regular treatment with an opioid in the 4 weeks before screening visit (infrequent use of tramadol, codeine, tilidine, or dihydrocodeine for no more than 10 days in the 4 weeks before the screening visit is acceptable, however, treatment must be stopped at screening visit)
- Diagnosis of major depression
- Treatment for epilepsy
- Corticosteroid injection within the last 3 months
- Major surgery in the 3 months before the start of the study
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 hydromorphone HCl4 to 32 mg taken orally once daily for 16 weeks | Drug | 001 |
| Placeboplacebo tablet once daily for 16 weeks | Drug | 002 |
Primary outcome
Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average)
Time frame: At each study visit from screening to week 16
The analgesic effect was assessed by the BPI item 5 "pain on average" using a 0 to 10 numeric rating scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine".
1 secondary outcome
The Number of Patients Discontinuing From the Trial Due to the Occurrence of an Adverse Event
Time frame: At each study visit from baseline until week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Placebo-controlled trial with OROS hydromorphone hydrochloride to treat patients with moderate to severe pain induced by osteoarthritis of the hip or the knee.Link provided by the sponsor.
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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.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OROS hydromorphone HCl in people with Pain and Osteoarthritis, Hip, run by Janssen-Cilag International NV at 12 sites in 4 countries.
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 4 inclusion and 6 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 25 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Czechia, Romania, Slovakia, United Kingdom. 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. 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 6 Sep 2010). 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?
Analgesic Effect as Assessed by Brief Pain Inventory (BPI) Item 5 Score (Pain on Average) (time frame: At each study visit from screening to week 16). 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 25 Apr 2014.