Chronic PainNCT01819805
A Study to Assess the Improvement of Pain and Health-Related Quality of Life in Patients With Chronic Non-Malignant Pain Taking Tramadol Hydrochloride and Acetaminophen
An observational study of Chronic Pain, run by Janssen Korea, Ltd., Korea at 14 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the impact of extended release tramadol hydrochloride (75 mg) and acetaminophen (650 mg) tablets on improvement of pain. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Pain
- Type of treatment
- Pill or oral medicine
- How many people
- 1,065 participants
- Where
- 14 sitesSouth Korea
- Study dates
- Sep 2011to Jul 2012
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic non-malignant pain taking tramadol hydrochloride and acetaminophen
Who may be able to join
- Patients with the prescription of ULTRACET ER for the treatment of moderate to severe pain
- Complaining of chronic pain for more than 3 months
Who cannot join
- Patient who had been treated with extended release tramadol hydrochloride (75mg) and acetaminophen (650mg) or strong opioids (eg, morphine, fentanyl, oxycodone, hydromorphone) within the past 4 weeks
- Patient with a severe mental disease and with a medical history of hypersensitivity to opioid analgesics
- Pregnant females or the females likely to become pregnant during the study period
- Patient who had been believed likely to complain of more pain than the real pain he or she is experiencing because of industrial disaster, car insurance, and others
- Patients who are contraindicated according to the warnings, precautions and prohibitions regarding extended release tramadol hydrochloride (75mg) and acetaminophen (650mg)
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
South Korea14 sites
Study site
Busan
Study site
Cheonan
Study site
Chungcheongbuk-Do
Study site
Chungju
Study site
Daegu
Study site
Daejeon
Study site
Goyang
Study site
Gyeonggi-do
Study site
Hwasun Gun
Study site
Kwangiu
Study site
Kwangjoo
Study site
Kyungjoo
Study site
Seoul
Study site
Suwon
About this study
Official title: Evaluation of the Improvement of Pain and Health-Related Quality of Life in Patients With Chronic Non-Malignant Pain Taking Tramadol HCl (75mg)/Acetaminophen (650mg) Extended Release Tablet: Multicenter, Open Label, Prospective, Observational Study
The purpose of this study is to evaluate the impact of extended release tramadol hydrochloride (75 mg) and acetaminophen (650 mg) tablets on improvement of pain.
Read the detailed description
This is a multi-center (study conducted at multiple sites), open label (all people know the identity of the intervention), prospective (in which the participants are first identified and then followed forward as time passes), observational study to assess the improvement of pain and health-related quality of life in patients with moderate to severe chronic non-malignant pain. The study will enroll patients who had already filled a prescription for extended release tramadol hydrochloride 75 mg and acetaminophen 650 mg (ULTRACET ER). The study medication will be administered according to local label insert. The study medication will be taken twice daily, 1 to 2 tablets each time, for a maximum of 4 tablets. Safety evaluations for adverse events will be performed throughout the study. The total duration of the study will be approximately of 12 weeks.
- Conditions
- Chronic Pain
- Being tested
- No intervention
- Keywords
- Chronic pain, Chronic non-malignant pain, Non-malignant, Pain, Extended release tablet, Tramadol hydrochloride, Tramadol HCl, Acetaminophen, Ultracet ER
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
Also called ULTRACET ER
This is an observational study. Patients taking extended release tramadol hydrochloride 75 mg and acetaminophen 650 mg orally twice daily will be observed.
| Study group | Role | What they receive |
|---|---|---|
| Patients taking tramadol hydrochloride and acetaminophen | Not described Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with more than 30 percentage reduction in percentage Pain Intensity Difference (PID) from baseline
Numerical Rating Scale (NRS) is an 11-point scale to measure the pain intensity and is used by patients to rate their pain from 0 (absence of pain) to 10 (extreme pain). Percentage PID =[(NRS score at baseline - NRS score at Week 12)/NRS score at baseline] X 100.
Measured: Baseline (Week 1) to Week 12
Secondary outcomes (7)
Change in scores of Korean version of the EuroQol 5 Dimensional (KEQ-5D) Questionnaire from baseline
The KEQ-5D is a validated generic measure of quality of life which usually requires less than 1 minute to complete (eg, the questionnaire may have questions about mobility, self care, usual activities, pain/discomfort and anxiety/depression).
Measured: Baseline to Week 12
The degree of night sleep disturbance due to pain
Sleep disturbance due to pain will be measured using a Numeric Rating Scale (NRS): 1 = None, 10 = Complete.
Measured: Baseline to Week 12
The degree of Interference with activity of daily living due to Pain
The degree of interference with activity of daily living due to pain will be assessed on a 5-point scale: 1 = No interference, 5 = Great interference. Activity of daily living means household work performance, etc.
Measured: Baseline to Week 12
The degree of Interference with social activities due to Pain
The degree of interference with social life performance due to pain will be measured on a 5-point scale; 1 = No interference, 5 = Great interference. Social activities means interpersonal relationship, going out, working life, etc.
Measured: Baseline to Week 12
The investigator's global assessment of pain treatment
The investigator will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been for a patient, in the judgment of the investigator.
Measured: Week 4 to Week 12
The patient's global assessment of pain treatment
The patient will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been in the judgment of the study patient.
Measured: Week 4 to Week 12
The number of patients who experience adverse events as a measure of safety and tolerability
Measured: Week 4 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startSep 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,065 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819805
- Sponsor's protocol ID
- CR100722
- Other IDs
- TRAMAPPAI4047, ULTER-KOR-5005
- Status last verified
- Dec 2014
- First submitted
- 7 Feb 2013
- Last updated
- 1 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Improvement of Pain and Health-Related Quality of Life in Patients With Chronic Non-Malignant Pain Taking Tramadol HCl (75mg)/Acetaminophen (650mg) Extended Release Tablet: Multicenter, Open Label, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT01819805
- Acronym / sponsor ID
- CR100722
- Conditions
- Chronic Pain
- Keywords
- Chronic pain, Chronic non-malignant pain, Non-malignant, Pain, Extended release tablet, Tramadol hydrochloride, Tramadol HCl, Acetaminophen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,065 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 28 Mar 2013 (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 purpose of this study is to evaluate the impact of extended release tramadol hydrochloride (75 mg) and acetaminophen (650 mg) tablets on improvement of pain.
Detailed description
This is a multi-center (study conducted at multiple sites), open label (all people know the identity of the intervention), prospective (in which the participants are first identified and then followed forward as time passes), observational study to assess the improvement of pain and health-related quality of life in patients with moderate to severe chronic non-malignant pain. The study will enroll patients who had already filled a prescription for extended release tramadol hydrochloride 75 mg and acetaminophen 650 mg (ULTRACET ER). The study medication will be administered according to local label insert. The study medication will be taken twice daily, 1 to 2 tablets each time, for a maximum of 4 tablets. Safety evaluations for adverse events will be performed throughout the study. The total duration of the study will be approximately of 12 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients taking tramadol hydrochloride and acetaminophen | – | Drug: No intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic non-malignant pain taking tramadol hydrochloride and acetaminophen
Key inclusion criteria (2 listed)
- Patients with the prescription of ULTRACET ER for the treatment of moderate to severe pain
- Complaining of chronic pain for more than 3 months
Key exclusion criteria (5 listed)
- Patient who had been treated with extended release tramadol hydrochloride (75mg) and acetaminophen (650mg) or strong opioids (eg, morphine, fentanyl, oxycodone, hydromorphone) within the past 4 weeks
- Patient with a severe mental disease and with a medical history of hypersensitivity to opioid analgesics
- Pregnant females or the females likely to become pregnant during the study period
- Patient who had been believed likely to complain of more pain than the real pain he or she is experiencing because of industrial disaster, car insurance, and others
- Patients who are contraindicated according to the warnings, precautions and prohibitions regarding extended release tramadol hydrochloride (75mg) and acetaminophen (650mg)
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 |
|---|---|---|
| No interventionAlso: ULTRACET ERThis is an observational study. Patients taking extended release tramadol hydrochloride 75 mg and acetaminophen 650 mg orally twice daily will be observed. | Drug | Patients taking tramadol hydrochloride and acetaminophen |
Primary outcome
Number of patients with more than 30 percentage reduction in percentage Pain Intensity Difference (PID) from baseline
Time frame: Baseline (Week 1) to Week 12
Numerical Rating Scale (NRS) is an 11-point scale to measure the pain intensity and is used by patients to rate their pain from 0 (absence of pain) to 10 (extreme pain). Percentage PID =[(NRS score at baseline - NRS score at Week 12)/NRS score at baseline] X 100.
7 secondary outcomes
Change in scores of Korean version of the EuroQol 5 Dimensional (KEQ-5D) Questionnaire from baseline
Time frame: Baseline to Week 12
The degree of night sleep disturbance due to pain
Time frame: Baseline to Week 12
The degree of Interference with activity of daily living due to Pain
Time frame: Baseline to Week 12
The degree of Interference with social activities due to Pain
Time frame: Baseline to Week 12
The investigator's global assessment of pain treatment
Time frame: Week 4 to Week 12
The patient's global assessment of pain treatment
Time frame: Week 4 to Week 12
The number of patients who experience adverse events as a measure of safety and tolerability
Time frame: Week 4 to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2015.
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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 Korea, Ltd., Korea Clinical trial study director
Janssen Korea, Ltd., Korea
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Janssen Korea, Ltd., Korea at 14 sites in South Korea.
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 2 inclusion and 5 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 1 Jan 2015. 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 South Korea. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of patients with more than 30 percentage reduction in percentage Pain Intensity Difference (PID) from baseline (time frame: Baseline (Week 1) to Week 12). 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 1 Jan 2015.