Amputation of Lower LimbPhase 4NCT00169013
Gabapentin in Phantom and Stump Pain
A Phase 4 study testing Gabapentin in people with Amputation of Lower Limb, run by Danish Pain Research Center at 1 site in Denmark.
Trial summary
To investigate whether gabapentin can prevent phantom and stump pain after amputation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation of Lower Limb
- What is being tested?
- Gabapentin
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- May 2002to Jun 2006
- Phase
- Phase 4
- 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
- 1. Amputation of crus or femur
Who cannot join
- Patients who cannot cooperate
- Fertile women without sufficient contraceptives
- Allergy to gabapentin
- Earlier amputation of the same limb except toes
- Serious lever, kidney, cardiac, respiratory, haematological disease.-
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Pain Research Center, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Gabapentin in the Prevention of Phantom Limb Pain
To investigate whether gabapentin can prevent phantom and stump pain after amputation.
- Conditions
- Amputation of Lower Limb
- Being tested
- Gabapentin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measures:
Number of patients with phantom and stump pain 30 days and 6 months after amputation
Average intensity of stump and phantom pain 30 days and 6 months after amputation
Secondary outcomes (5)
Secondary outcome measures:
Prevalence and severity of phantom and stump pain at controls day 7, 14 and 30, and 3 and 6 months
McGill Pain Questionnaire day 7, 14 and 30, and 3 and 6 months
Concurrent pain medication at day 7, 14 and 30, and 3 and 6 months
Brush evoked allodynia, wind up like pain to repetitive pinprick, pressure pain threshold at day 14 and 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 2002
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation of Lower LimbStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Danish Pain Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Lone Nikolajsen, MD, PhD, Principal investigator, Danish Pain Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169013
- Sponsor's protocol ID
- Gabapentin2002
- Status last verified
- Apr 2007
- First submitted
- 9 Sep 2005
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin in the Prevention of Phantom Limb Pain
- ClinicalTrials.gov ID
- NCT00169013
- Acronym / sponsor ID
- Gabapentin2002
- Conditions
- Amputation of Lower Limb
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Danish Pain Research CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2002
- Study completion
- Jun 2006
- First posted
- 15 Sep 2005 (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.
To investigate whether gabapentin can prevent phantom and stump pain after amputation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Amputation of crus or femur
Key exclusion criteria (5 listed)
- Patients who cannot cooperate
- Fertile women without sufficient contraceptives
- Allergy to gabapentin
- Earlier amputation of the same limb except toes
- Serious lever, kidney, cardiac, respiratory, haematological 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 |
|---|---|---|
| Gabapentin | Drug | – |
Primary outcome
Primary outcome measures:
Number of patients with phantom and stump pain 30 days and 6 months after amputation
Average intensity of stump and phantom pain 30 days and 6 months after amputation
5 secondary outcomes
Secondary outcome measures:
Prevalence and severity of phantom and stump pain at controls day 7, 14 and 30, and 3 and 6 months
McGill Pain Questionnaire day 7, 14 and 30, and 3 and 6 months
Concurrent pain medication at day 7, 14 and 30, and 3 and 6 months
Brush evoked allodynia, wind up like pain to repetitive pinprick, pressure pain threshold at day 14 and 30.
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 9 Aug 2024.
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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.
Lone Nikolajsen, MD, PhD principal investigator
Danish Pain Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin in people with Amputation of Lower Limb, run by Danish Pain Research Center at 1 site in Denmark.
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 1 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 9 Aug 2024. 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary outcome measures:. The study lists 3 primary outcomes in all. 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 9 Aug 2024.