GabapentinNCT06613802
Prevalence of Gabapentinoids and Opioids in Geriatric Falls Patients
An observational study of Gabapentin, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
This study investigates the prescription patterns of gabapentinoids (gabapentin and pregabalin) in a geriatric fall clinic in Aalborg, Denmark, between 2013 and 2023. Gabapentinoids, often prescribed for neuropathic pain, have seen increased off-label usage, particularly as alternatives to opioids. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gabapentin
- What is being tested?
- Time
- How many people
- 800 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2024to 1 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The entire sample will be included. It is expected that the prevalence in 2013 is twice (6%) that of the background population (3%). Sample size calculations at 80% power and 5% significance based on differences in population between 2023 (estimated 20%, which is twice that of 2023 background population of 10%) shows that 90 participants are required. Thus it is expected to include the whole of 2013, 2018 and every second patient in 2023 based on this. However, if the prevalence is lower than expected in 2013 then 2014, 2019 and all patients in 2023 will be included.
Who may be able to join
- patient in the geriatric fall clinic at Aalborg University Hospital in either 2013-2014, 2018-2019, or 2023
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Gabapentinoids in Geriatric Falls Outpatients in Aalborg in 2013-2014, 2018-2019, and 2023
This study investigates the prescription patterns of gabapentinoids (gabapentin and pregabalin) in a geriatric fall clinic in Aalborg, Denmark, between 2013 and 2023. Gabapentinoids, often prescribed for neuropathic pain, have seen increased off-label usage, particularly as alternatives to opioids. Despite the lack of robust evidence supporting their efficacy in many neuropathic and non-neuropathic pain conditions, their use has grown, especially in elderly populations. This raises concerns about their potential side effects, such as drowsiness, dizziness, and the risk of falls, especially when combined with opioids.
The study aims to determine the prevalence of gabapentinoid and opioid prescriptions in the clinics and for what type of pain they are prescribed. Furthermore, the study will look into the development in opioid prescriptions and concomitant gabapentinoid/opioid usage in this population.
The study is a retrospective chart review of patient charts from the years 2013-2014, 2018-2019, and 2023, analyzing patient characteristics, comorbidities, medication lists, and pain classifications.
- Conditions
- Gabapentin
- Being tested
- Time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TimeOther
This is a cross sectional study, and the exposure where the outcome is expected to change by is time. Years included in the study are 2013-2014, 2018-2019 and 2023
| Study group | Role | What they receive |
|---|---|---|
| 2013-2014 | Patients in 2013-2014. All fall patient charts will be included depending on the prevalence of gabapentionoid prescriptions. It is expected that the prevalence in 2013 is twice (6%) that of the background population (3%). Sample size calculations at 80% power and 5% significance based on differences in population between 2023 (estimated 20%, which is twice that of 2023 background population of 10%) shows that 90 participants are required. Thus it is expected to include the whole of 2013. However, if the prevalence is lower than expected, 2014 will also be included. The sample size required prevalences of 3% in 2013 and 10% in 2023 is 194, which would be met by expanding the sampling frame to encompass 2014. Receives: Other: Time | |
| 2018-2019 | All patients in 2018 will be included. If it is necessary to also include 2014 as described above, then 2019 will also be included to ensure approximately equal group sizes. Receives: Other: Time | |
| 2023 | More patients were seen in 2023, with a total of 254 available. If only 2013 is included based on the prevalence as stated above, then every second patient from 2023 will be included. If 2014 is also included then all patient from 2023 will be included to ensure approximately equal group sizes. Receives: Other: Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of gabapentionoids
Number of patients taking gabapentinoids (yes/no) for each year
Measured: Baseline. That is at the time of first outpatient contact in the geriatric fall clinic at Aalborg University Hospital
Prevalence of opioids
Number of patients taking opioids (yes/no) for each year
Measured: Baseline. That is at the time of first outpatient contact in the geriatric fall clinic at Aalborg University Hospital
Secondary outcomes (1)
Pain characteristics for each year
Pain categorized as malignant, neuropathic (with subcategories such as radiculopathy, postherpetic neuralgia), nociceptive somatic (e.g., back pain, shoulder pain), and nociceptive visceral (e.g., headache, abdominal pain). Each pain type will further be classified by duration as acute (below 3 months), subacute (3-6 months), chronic (more than 6 months), or "not stated in charts".
Measured: Baseline. That is at the time of first outpatient contact in the geriatric fall clinic at Aalborg University Hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start1 Oct 2024
- Primary completion1 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GabapentinStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Riis, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613802
- Sponsor's protocol ID
- F2024-085
- Status last verified
- Jan 2025
- First submitted
- 12 Sep 2024
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Gabapentinoids in Geriatric Falls Outpatients in Aalborg in 2013-2014, 2018-2019, and 2023
- ClinicalTrials.gov ID
- NCT06613802
- Acronym / sponsor ID
- F2024-085
- Conditions
- Gabapentin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 26 Sep 2024 (actual)
- 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 study investigates the prescription patterns of gabapentinoids (gabapentin and pregabalin) in a geriatric fall clinic in Aalborg, Denmark, between 2013 and 2023. Gabapentinoids, often prescribed for neuropathic pain, have seen increased off-label usage, particularly as alternatives to opioids. Despite the lack of robust evidence supporting their efficacy in many neuropathic and non-neuropathic pain conditions, their use has grown, especially in elderly populations. This raises concerns about their potential side effects, such as drowsiness, dizziness, and the risk of falls, especially when combined with opioids.
The study aims to determine the prevalence of gabapentinoid and opioid prescriptions in the clinics and for what type of pain they are prescribed. Furthermore, the study will look into the development in opioid prescriptions and concomitant gabapentinoid/opioid usage in this population.
The study is a retrospective chart review of patient charts from the years 2013-2014, 2018-2019, and 2023, analyzing patient characteristics, comorbidities, medication lists, and pain classifications.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2013-2014 | – | Other: TimePatients in 2013-2014. All fall patient charts will be included depending on the prevalence of gabapentionoid prescriptions. It is expected that the prevalence in 2013 is twice (6%) that of the background population (3%). Sample size calculations at 80% power and 5% significance based on differences in population between 2023 (estimated 20%, which is twice that of 2023 background population of 10%) shows that 90 participants are required. Thus it is expected to include the whole of 2013. However, if the prevalence is lower than expected, 2014 will also be included. The sample size required prevalences of 3% in 2013 and 10% in 2023 is 194, which would be met by expanding the sampling frame to encompass 2014. |
| 2018-2019 | – | Other: TimeAll patients in 2018 will be included. If it is necessary to also include 2014 as described above, then 2019 will also be included to ensure approximately equal group sizes. |
| 2023 | – | Other: TimeMore patients were seen in 2023, with a total of 254 available. If only 2013 is included based on the prevalence as stated above, then every second patient from 2023 will be included. If 2014 is also included then all patient from 2023 will be included to ensure approximately equal group sizes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The entire sample will be included. It is expected that the prevalence in 2013 is twice (6%) that of the background population (3%). Sample size calculations at 80% power and 5% significance based on differences in population between 2023 (estimated 20%, which is twice that of 2023 background population of 10%) shows that 90 participants are required. Thus it is expected to include the whole of 2013, 2018 and every second patient in 2023 based on this. However, if the prevalence is lower than expected in 2013 then 2014, 2019 and all patients in 2023 will be included.
Key inclusion criteria (1 listed)
- patient in the geriatric fall clinic at Aalborg University Hospital in either 2013-2014, 2018-2019, or 2023
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| TimeThis is a cross sectional study, and the exposure where the outcome is expected to change by is time. Years included in the study are 2013-2014, 2018-2019 and 2023 | Other | 2013-2014, 2018-2019, 2023 |
Primary outcome
Prevalence of gabapentionoids
Time frame: Baseline. That is at the time of first outpatient contact in the geriatric fall clinic at Aalborg University Hospital
Number of patients taking gabapentinoids (yes/no) for each year
Prevalence of opioids
Time frame: Baseline. That is at the time of first outpatient contact in the geriatric fall clinic at Aalborg University Hospital
Number of patients taking opioids (yes/no) for each year
1 secondary outcome
Pain characteristics for each year
Time frame: Baseline. That is at the time of first outpatient contact in the geriatric fall clinic at Aalborg University Hospital
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 15 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gabapentin, run by Aalborg University Hospital 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 1 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 15 Jul 2025. 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.
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?
Prevalence of gabapentionoids (time frame: Baseline. That is at the time of first outpatient contact in the geriatric fall clinic at Aalborg University Hospital). The study lists 2 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 15 Jul 2025.