PainPhase 3NCT01776671
Once Daily Gabapentin in the Treatment of Post Amputation Pain
A Phase 3 study testing Gralise in people with Pain and Quality of Life, run by Chicago Anesthesia Pain Specialists at 1 site in United States.
Trial summary
Phantom limb pain (PLP) is a common disorder reported by the patients who undergo amputation. Even though the cause of PLP remains unclear, Gabapentin has been widely used. The purpose of this study is to evaluate the accuracy and efficacy achieved in using of extended release Gabapentin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Quality of Life
- What is being tested?
- Gralise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Dec 2018
- 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
- Subject must have post amputation pain persisting for more than six months.
- Be considered in reasonably good health, in the opinion of the investigator, other than the post amputation pain at the screening visit (based upon the results of the medical and surgical history, vital signs, pulse oximetry and physical examination.
- Be ≥ 18 years of age at the time of screening.
- Female subject are eligible only if all of the following apply:
- Not pregnant ( negative serum pregnancy test at the screening visit);
- Not lactating
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- Consented to use barrier contraceptive methods to avoid pregnancy beginning at least 10 days before check -in and continuing throughout the study up to month after the end of the study.
- Voluntarily provide written informed consent.
- Must in the investigator's opinion, to be able to comply with the study procedure.
Who cannot join
- Hypersensitivity or allergy to gabapentin
- History of co-existing epilepsy or uncontrolled seizure disorder
- Subject is suffering from dementia or any cognitive dysfunction
- Have an uncontrolled or poorly controlled major psychiatric condition (e.g. schizophrenia, major depression) or who have clinically significant anxiety or depression
- Severe cardiopulmonary or liver disease
- Impaired kidney function testing
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- Patient receiving hemodialysis
- Subjects with current uncontrolled depression or other uncontrolled psychiatric disorder
- Subjects currently taking anticonvulsants for any reason of treatment
- History of untreated alcohol abuse
- History of gastrointestinal symptoms such as: diarrhea, dyspepsia or gastro duodenal ulcers
- Subjects with history of gastric reduction surgery
- Any other clinically significant condition, or unstable inter-current illness that would, in the opinion of the investigator, preclude study participation or interfere with the assessment of the pain
- Clinically significant of uncontrolled hypo or hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Chicago Anesthesia Pain Specialists
Chicago, Illinois, 60639
About this study
Official title: Efficacy of Once Daily Gastroretentive Gabapentin (Gralise) in the Treatment of Post Amputation Pain
Phantom limb pain (PLP) is a common disorder reported by the patients who undergo amputation. Even though the cause of PLP remains unclear, Gabapentin has been widely used. The purpose of this study is to evaluate the accuracy and efficacy achieved in using of extended release Gabapentin. Reducing the incidence of chronic post-amputation pain and improving clinical outcomes postoperatively.
Read the detailed description
Phantom limb pain (PLP) is a common disorder reported by the patients who undergo amputation from peripheral vascular disease, peripheral neuropathic disease, neoplasm or traumatic events. Even though the cause of PLP remains unclear and the large number of treatments has been suggested, there is no single treatment regimen proving long lasting pain relief for PLP. However Gabapentin is widely used and have been well suggested recently for the treatment of neuropathic pain.
The purpose of this study is to evaluate the accuracy and efficacy achieved in using of extended release Gabapentin to offer effective pain relief, improvement of sleep function, and decrease problematic side effects related to the peaks and valleys of the drug's short cycle in patients with PLP. Gabapentin has been clearly demonstrated to be effective in neuropathic pain and epilepsy, but as a treatment option for post amputation pain, it has not been tested.
Approximately, 20 patients will be enrolled in the study, after a titration of two weeks a changing in pain intensity and quality of life will be obtained at subsequent visits. We are expected that the accuracy will be of benefit in reducing the incidence of chronic post-amputation pain and improving clinical outcomes postoperatively.
- Conditions
- Pain, Quality of Life
- Being tested
- Gralise
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GraliseDrug
Titration starting 300 mg/day up to 1800 mg/day over 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Gralise | Other | Efficacy of Gralise Receives: Drug: Gralise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Numeric Rating Scale at rest
Visit 1, baseline; visit 2, one week after visit one; visit 3, two weeks after visit 1; visit 4, two weeks after visit 3; visit 5, six weeks after visit 3; visit 6, two weeks after visit 5.
Measured: Visit 1, 2, 3, 4, 5, 6
Secondary outcomes (1)
Change in Pain numeric rating scale at movement.
Visit 1, baseline; visit 2, one week after visit one; visit 3, two weeks after visit 1; visit 4, two weeks after visit 3; visit 5, six weeks after visit 3; visit 6, two weeks after visit 5.
Measured: Visit 1, 2, 3, 4, 5, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chicago Anesthesia Pain Specialists
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth D Candido, Chicago Anesthesia Pain Specialists
- Investigators
- Kenneth D Candido, M.D., Principal investigator, Chicago Anesthesia Pain Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01776671
- Sponsor's protocol ID
- Advocate-IRB-5367
- Status last verified
- Sep 2017
- First submitted
- 24 Jan 2013
- Last updated
- 14 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Once Daily Gastroretentive Gabapentin (Gralise) in the Treatment of Post Amputation Pain
- ClinicalTrials.gov ID
- NCT01776671
- Acronym / sponsor ID
- Advocate-IRB-5367
- Conditions
- Pain, Quality of Life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chicago Anesthesia Pain SpecialistsUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 Jan 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.
Phantom limb pain (PLP) is a common disorder reported by the patients who undergo amputation. Even though the cause of PLP remains unclear, Gabapentin has been widely used. The purpose of this study is to evaluate the accuracy and efficacy achieved in using of extended release Gabapentin. Reducing the incidence of chronic post-amputation pain and improving clinical outcomes postoperatively.
Detailed description
Phantom limb pain (PLP) is a common disorder reported by the patients who undergo amputation from peripheral vascular disease, peripheral neuropathic disease, neoplasm or traumatic events. Even though the cause of PLP remains unclear and the large number of treatments has been suggested, there is no single treatment regimen proving long lasting pain relief for PLP. However Gabapentin is widely used and have been well suggested recently for the treatment of neuropathic pain.
The purpose of this study is to evaluate the accuracy and efficacy achieved in using of extended release Gabapentin to offer effective pain relief, improvement of sleep function, and decrease problematic side effects related to the peaks and valleys of the drug's short cycle in patients with PLP. Gabapentin has been clearly demonstrated to be effective in neuropathic pain and epilepsy, but as a treatment option for post amputation pain, it has not been tested.
Approximately, 20 patients will be enrolled in the study, after a titration of two weeks a changing in pain intensity and quality of life will be obtained at subsequent visits. We are expected that the accuracy will be of benefit in reducing the incidence of chronic post-amputation pain and improving clinical outcomes postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gralise | Other | Drug: GraliseEfficacy of Gralise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject must have post amputation pain persisting for more than six months.
- Be considered in reasonably good health, in the opinion of the investigator, other than the post amputation pain at the screening visit (based upon the results of the medical and surgical history, vital signs, pulse oximetry and physical examination.
- Be ≥ 18 years of age at the time of screening.
- Female subject are eligible only if all of the following apply:
- Voluntarily provide written informed consent.
Key exclusion criteria (14 listed)
- Hypersensitivity or allergy to gabapentin
- History of co-existing epilepsy or uncontrolled seizure disorder
- Subject is suffering from dementia or any cognitive dysfunction
- Have an uncontrolled or poorly controlled major psychiatric condition (e.g. schizophrenia, major depression) or who have clinically significant anxiety or depression
- Severe cardiopulmonary or liver disease
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 |
|---|---|---|
| GraliseTitration starting 300 mg/day up to 1800 mg/day over 2 weeks | Drug | Gralise |
Primary outcome
Change in Pain Numeric Rating Scale at rest
Time frame: Visit 1, 2, 3, 4, 5, 6
Visit 1, baseline; visit 2, one week after visit one; visit 3, two weeks after visit 1; visit 4, two weeks after visit 3; visit 5, six weeks after visit 3; visit 6, two weeks after visit 5.
1 secondary outcome
Change in Pain numeric rating scale at movement.
Time frame: Visit 1, 2, 3, 4, 5, 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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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.
Kenneth D Candido, M.D. principal investigator
Chicago Anesthesia Pain Specialists
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gralise in people with Pain and Quality of Life, run by Chicago Anesthesia Pain Specialists 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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 14 Sep 2017. 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.
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?
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?
Change in Pain Numeric Rating Scale at rest (time frame: Visit 1, 2, 3, 4, 5, 6). 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 14 Sep 2017.