Systemic Lupus ErythematosusNCT01269866
Study of Duloxetine in the Reduction of Pain in Patient With Systemic Lupus Erythematosus
A study testing Cymbalta in people with Systemic Lupus Erythematosus, run by Dr. Jesus Gutierrez Stone at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Duloxetine (cymbalta) can reduce pain severity in patient with Systemic Lupus Erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Cymbalta
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to May 2012
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) classification criteria, before visit 1.
- Able to swallow all required medication without opening or crushing.
- Male or female outpatient 18-65 years old at visit 1.
- Painful physical symptoms with a frequency > or equal to 2 times per week.
- Painful physical symptoms with a score > or equal to 4 on the BPI- SF average pain question at visits 1 and 2.
- Clinical Global Impression of Severity (CGI-S) score 3 or higher at visit 1.
- Able to speak, read and provide informed consent.
- Judged by the investigator to be reliable and agree to keep all appointments.
Who cannot join
- Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit.
- Pregnancy, nursing. Women of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopausal) who are not using a medically accepted means of contraception (For example, oral contraceptive, contraceptive patch, implant, Depo-Provera®, Norplant®, reliable barrier method/devices [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]
- Positive urine drug screen for any substance of abuse. Note: If the subject has a positive drug screen for a substance at Visit 1, a retest may be performed prior to Visit 2 if, in the judgment of the investigator, there is an acceptable explanation for the positive result. A retest is not required for a positive result for benzodiazepines or hypnotics if the investigator confirms use is within protocol criteria.
- Serious medical illness, including any cardiovascular, hepatic, renal respiratory hematologic, endocrinologic or neurologic disease, or significant laboratory abnormality as judged by investigator.
- Substance/alcohol abuse or dependency in the last 6 months.
- History of serious suicide attempt or subject judged clinically to be at serious suicidal risk in the opinion of the investigator.
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- Uncontrolled narrow angle glaucoma.
- Known hypersensitivity to Duloxetine or any active ingredients.
- Treatment with a MAOI within 14 days prior to Visit 2 or have the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug. (See Concomitant Medication List)
- Have epilepsy or history of seizure disorder.
- Use of any of the prohibited medications including thioridazine (Mellaril), or all the potent CYP1A2 inhibitors, that use of these drugs are excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duloxetine (Cymbalta) in the Reduction of Pain Severity in Patient With Systemic Lupus Erythematosus: A Pilot Study
The purpose of this study is to determine whether Duloxetine (cymbalta) can reduce pain severity in patient with Systemic Lupus Erythematosus.
Read the detailed description
Duloxetine (Cymbalta) is a reuptake inhibitor of both serotonin and norepinephrine. By increasing levels of serotonin and norepinephrine, the descending inhibitory pain pathways may function better. These pathways lessen the perception of pain. Results of double blind, placebo controlled, clinical trials investigating the effectiveness of Duloxetine (Cymbalta) have shown that at doses of 60 mg once a day or 60 mg twice a day, Duloxetine (Cymbalta) demonstrated significantly higher rates of treatment response for pain when compared to placebo.
Given the positive findings in other clinical trial studies for Duloxetine (Cymbalta) such as Diabetic Peripheral Neuropathy (Raskin et al., 2005) and Fibromyalgia (e.g. Arnold et al., 2005), the investigators hypothesize that Duloxetine (Cymbalta) may reduce the pain severity, frequency and intensity of exacerbations in patients with SLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Cymbalta
- Keywords
- Lupus Pain, Lupus, Pain, Systemic Lupus Erythematosus, Duloxetine, Cymbalta
- Medical subject headings
- Lupus Erythematosus, Systemic, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CymbaltaDrug
Also called Duloxetine
Cymbalta 60 to 120 mg PO QD
| Study group | Role | What they receive |
|---|---|---|
| Cymbalta | Other | Cymbalta 60 to 120 mg Receives: Drug: Cymbalta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Brief Pan Inventory average pain questionnaire
This is a pilot study designed to explore the efficacy of Duloxetine (Cymbalta) 60 mg to 120 mg once daily (QD) on the reduction of pain in patients with Lupus pain. The primary objective will be measured by comparing changes from baseline and end of study in:
- The Brief Pain Inventory (BPI-SF) average pain questionnaire.
Measured: Up to 8 weeks
Secondary outcomes (1)
1. Change in Patient Global Impression of Improvement (PGI-I) score 2. Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score. 3. Change in Clinician Global of Impression (CGI) score
- Change in Patient Global Impression of Improvement (PGI-I) score
- Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.
- Change in Clinician Global of Impression (CGI) score
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Jesus Gutierrez Stone
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Jesus Gutierrez Stone, Brain Resource Center
- Investigators
- Jesus Gutierrez Stone, MD, Principal investigator, Brain Resouce Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269866
- Sponsor's protocol ID
- F1J-US-X059
- Status last verified
- Feb 2013
- First submitted
- 3 Jan 2011
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine (Cymbalta) in the Reduction of Pain Severity in Patient With Systemic Lupus Erythematosus: A Pilot Study
- ClinicalTrials.gov ID
- NCT01269866
- Acronym / sponsor ID
- F1J-US-X059
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Lupus Pain, Lupus, Pain, Systemic Lupus Erythematosus, Duloxetine, Cymbalta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dr. Jesus Gutierrez StoneUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 4 Jan 2011 (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 determine whether Duloxetine (cymbalta) can reduce pain severity in patient with Systemic Lupus Erythematosus.
Detailed description
Duloxetine (Cymbalta) is a reuptake inhibitor of both serotonin and norepinephrine. By increasing levels of serotonin and norepinephrine, the descending inhibitory pain pathways may function better. These pathways lessen the perception of pain. Results of double blind, placebo controlled, clinical trials investigating the effectiveness of Duloxetine (Cymbalta) have shown that at doses of 60 mg once a day or 60 mg twice a day, Duloxetine (Cymbalta) demonstrated significantly higher rates of treatment response for pain when compared to placebo.
Given the positive findings in other clinical trial studies for Duloxetine (Cymbalta) such as Diabetic Peripheral Neuropathy (Raskin et al., 2005) and Fibromyalgia (e.g. Arnold et al., 2005), the investigators hypothesize that Duloxetine (Cymbalta) may reduce the pain severity, frequency and intensity of exacerbations in patients with SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cymbalta | Other | Drug: CymbaltaCymbalta 60 to 120 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A diagnosis of Systemic Lupus Erythematosus (SLE) according to the American College of Rheumatology (ACR) classification criteria, before visit 1.
- Able to swallow all required medication without opening or crushing.
- Male or female outpatient 18-65 years old at visit 1.
- Painful physical symptoms with a frequency > or equal to 2 times per week.
- Painful physical symptoms with a score > or equal to 4 on the BPI- SF average pain question at visits 1 and 2.
Key exclusion criteria (11 listed)
- Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit.
- Pregnancy, nursing. Women of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopausal) who are not using a medically accepted means of contraception (For example, oral contraceptive, contraceptive patch, implant, Depo-Provera®, Norplant®, reliable barrier method/devices [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]
- Positive urine drug screen for any substance of abuse. Note: If the subject has a positive drug screen for a substance at Visit 1, a retest may be performed prior to Visit 2 if, in the judgment of the investigator, there is an acceptable explanation for the positive result. A retest is not required for a positive result for benzodiazepines or hypnotics if the investigator confirms use is within protocol criteria.
- Serious medical illness, including any cardiovascular, hepatic, renal respiratory hematologic, endocrinologic or neurologic disease, or significant laboratory abnormality as judged by investigator.
- Substance/alcohol abuse or dependency in the last 6 months.
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 |
|---|---|---|
| CymbaltaAlso: DuloxetineCymbalta 60 to 120 mg PO QD | Drug | Cymbalta |
Primary outcome
Changes in the Brief Pan Inventory average pain questionnaire
Time frame: Up to 8 weeks
This is a pilot study designed to explore the efficacy of Duloxetine (Cymbalta) 60 mg to 120 mg once daily (QD) on the reduction of pain in patients with Lupus pain. The primary objective will be measured by comparing changes from baseline and end of study in: 1. The Brief Pain Inventory (BPI-SF) average pain questionnaire.
1 secondary outcome
1. Change in Patient Global Impression of Improvement (PGI-I) score 2. Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score. 3. Change in Clinician Global of Impression (CGI) score
Time frame: Up to 8 weeks
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 5 Feb 2013.
- Click here for more information about this studyLink 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.
Jesus Gutierrez Stone, MD principal investigator
Brain Resouce Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cymbalta in people with Systemic Lupus Erythematosus, run by Dr. Jesus Gutierrez Stone at 1 site 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 8 inclusion and 11 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 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Changes in the Brief Pan Inventory average pain questionnaire (time frame: Up to 8 weeks). 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 5 Feb 2013.