Chronic Phantom Limb PainNCT00425230
Open Label Study of Duloxetine for the Treatment of Phantom Limb Pain
A study testing Duloxetine in people with Chronic Phantom Limb Pain, run by Baylor College of Medicine at 1 site in United States.
Trial summary
This is a study to assess the possible benefit of duloxetine in the treatment of chronic phantom limb pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Phantom Limb Pain
- What is being tested?
- Duloxetine
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Jun 2007
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic PLP > 6 months
- Short-Form McGill Pain Questionnaire Sensory Pain Rating Index raw score ≥ 16
- Age ≥ 18 years old
- Inpatient or Outpatient
- Able to come to all appointments, in the opinion of the investigator
- Able to give informed consent, in opinion of investigator
Who cannot join
- Current Major Depressive disorder, Anxiety Disorder, or Psychotic disorder assessed by the Mini International Neuropsychiatric Interview (MINI)
- Substance abuse or dependence within the last six months, as assessed by the MINI
- Known Diabetes Mellitus to exclude diabetic peripheral neuropathy
- History of coronary artery disease, hepatic disease, renal disease
- Other pain syndromes
- Any unstable medical conditions in the opinion of the investigator
- Other psychotropic medications excluding hypnotics
Trial locations and contacts
1 site in 1 country.
United States1 site
Micheal E. DeBakey Veterans Hospital
Houston, Texas, 77030
About this study
Official title: Pilot Study of Use of Duloxetine for the Treatment of Phantom Limb Pain
This is a study to assess the possible benefit of duloxetine in the treatment of chronic phantom limb pain.
- Conditions
- Chronic Phantom Limb Pain
- Being tested
- Duloxetine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
McGill Short Form Pain Questionairre
Secondary outcomes (4)
Fiser Side effect scale
visual analog pain scale
Present Pain intensity
Tylenol # 3 consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2007 (estimated)
- Study startJan 2007
- Study completionJun 2007
Why it stopped: No patients were enrolled in this study. The study onset was delayed due to problems with drug acquisition.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Phantom Limb PainStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Goodman MD, Baylor College of Medicine
- Investigators
- Asif Chaudhry, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425230
- Sponsor's protocol ID
- H-19539
- Status last verified
- Aug 2022
- First submitted
- 19 Jan 2007
- Last updated
- 12 Aug 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Use of Duloxetine for the Treatment of Phantom Limb Pain
- ClinicalTrials.gov ID
- NCT00425230
- Acronym / sponsor ID
- H-19539
- Conditions
- Chronic Phantom Limb Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No patients were enrolled in this study. The study onset was delayed due to problems with drug acquisition.
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Jun 2007
- First posted
- 22 Jan 2007 (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.
This is a study to assess the possible benefit of duloxetine in the treatment of chronic phantom limb pain.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic PLP > 6 months
- Short-Form McGill Pain Questionnaire Sensory Pain Rating Index raw score ≥ 16
- Age ≥ 18 years old
- Inpatient or Outpatient
- Able to come to all appointments, in the opinion of the investigator
Key exclusion criteria (7 listed)
- Current Major Depressive disorder, Anxiety Disorder, or Psychotic disorder assessed by the Mini International Neuropsychiatric Interview (MINI)
- Substance abuse or dependence within the last six months, as assessed by the MINI
- Known Diabetes Mellitus to exclude diabetic peripheral neuropathy
- History of coronary artery disease, hepatic disease, renal disease
- Other pain syndromes
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 |
|---|---|---|
| Duloxetine | Drug | – |
Primary outcome
McGill Short Form Pain Questionairre
4 secondary outcomes
Fiser Side effect scale
visual analog pain scale
Present Pain intensity
Tylenol # 3 consumption
Results and safety
The study was stopped early (reason given: No patients were enrolled in this study. The study onset was delayed due to problems with drug acquisition.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
Related trials for Chronic Phantom Limb Pain
Recruiting
Target Muscle Re-innervation and Regenerative Peripheral Nerve Interfaces Alone and in Combination for the Treatment of Residual and Phantom Limb Pain in Cancer Patients Who Have Received an Amputation
Amputation
Active, not recruitingPhase 1
Psilocybin-assisted Therapy for Phantom Limb Pain
Phantom Limb Pain
RecruitingObservational study
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
Sensation Disorders, Sensation, Phantom
Not yet recruitingObservational study
Post-Amputation Stump Infection as a Predictor of Persistent Residual Limb Pain: A Prospective Cohort Study
Residual Limb Pain, Stump Pain
Not yet recruitingObservational study
Venous Thromboembolism and Chronic Pain After Major Limb Trauma
VTE (Venous Thromboembolism), Phantom Limb Pain After Amputation
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.
Asif Chaudhry, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duloxetine in people with Chronic Phantom Limb Pain, run by Baylor College of Medicine 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 6 inclusion and 7 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 12 Aug 2022. 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 was stopped early (reason given: No patients were enrolled in this study. The study onset was delayed due to problems with drug acquisition.). 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?
McGill Short Form Pain Questionairre. 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 12 Aug 2022.