Chronic PainPhase 3pregabalinNCT00772291
Chronic Pain Management After Herniorraphy
A Phase 3 study testing pregabalin in people with Chronic Pain, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Nowadays, chronic pain mainly as a result of iatrogenic nerve damage is generally considered as the most frequent complication after inguinal hernia surgery. The primary objective of this randomised double-blind placebo-controlled trial is to investigate whether pregabalin reduces pain in patients with chronic pain of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- pregabalin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2007to Oct 2010
- 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
- History of unilateral inguinal herniotomy
- Establishment of neuropathic character of chronic pain by means the LANSS painscore and DN4 score
- Abnormal sensitivity (allodynia, dysesthesia, hypoesthesia or dysesthesia) in or around the incisional area
- Duration pain ≥ 3 months
- Medial or lateral inguinal hernia
- Age ≥ 18 years
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- VAS score ≥ 40 mm on Vas scale on which they indicate 'how unpleasant or disturbing the worst pain was that they had today'
- Grade III or IV pain and discomfort on the 4-point pain and discomfort scale
- Informed consent (addendum V)
Who cannot join
- Participation in another trial
- Age < 18 years
- Cognitive disfunction
- Patient is unable to speak Dutch
- Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption
- Patient classified as American Society of Anaesthesiologist Class 4
- Renal impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Pain Management After Herniorraphy:Pregabalin vs Placebo. A Double-blinded Randomised Controlled Clinical Trial.
Nowadays, chronic pain mainly as a result of iatrogenic nerve damage is generally considered as the most frequent complication after inguinal hernia surgery. The primary objective of this randomised double-blind placebo-controlled trial is to investigate whether pregabalin reduces pain in patients with chronic pain of neuropathic origin after herniorraphy.
- Conditions
- Chronic Pain
- Being tested
- pregabalin, placebo
- Keywords
- inguinal, hernia, chronic, pain, pregabalin, chronic pain after inguinal herniorraphy
- Medical subject headings
- Chronic Pain, Hernia, Bronchiolitis Obliterans Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pregabalinDrug
pregabalin 150-600mg/day during 8 weeks
placeboDrug
placebo drug during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| pregabalin | Active comparator | Not described Receives: Drug: pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Measured: 8 weeks
Secondary outcomes (1)
quantitative sensory testing (QST) accuracy in testing the inguinal region
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startMay 2007
- Primary completionAug 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hasan eker, Erasmus Medical Center
- Investigators
- J.F. Lange, professor, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772291
- Sponsor's protocol ID
- pregabalin RCT
- Acronym
- pregabalin
- Status last verified
- Aug 2011
- First submitted
- 13 Oct 2008
- Last updated
- 19 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain Management After Herniorraphy:Pregabalin vs Placebo. A Double-blinded Randomised Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT00772291
- Acronym / sponsor ID
- pregabalin / pregabalin RCT
- Conditions
- Chronic Pain
- Keywords
- inguinal, hernia, chronic, pain, pregabalin, chronic pain after inguinal herniorraphy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 15 Oct 2008 (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.
Nowadays, chronic pain mainly as a result of iatrogenic nerve damage is generally considered as the most frequent complication after inguinal hernia surgery. The primary objective of this randomised double-blind placebo-controlled trial is to investigate whether pregabalin reduces pain in patients with chronic pain of neuropathic origin after herniorraphy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo |
| pregabalin | Active comparator | Drug: pregabalin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- History of unilateral inguinal herniotomy
- Establishment of neuropathic character of chronic pain by means the LANSS painscore and DN4 score
- Abnormal sensitivity (allodynia, dysesthesia, hypoesthesia or dysesthesia) in or around the incisional area
- Duration pain ≥ 3 months
- Medial or lateral inguinal hernia
Key exclusion criteria (7 listed)
- Participation in another trial
- Age < 18 years
- Cognitive disfunction
- Patient is unable to speak Dutch
- Hereditary problems of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption
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 |
|---|---|---|
| pregabalinpregabalin 150-600mg/day during 8 weeks | Drug | pregabalin |
| placeboplacebo drug during 8 weeks | Drug | placebo |
Primary outcome
pain
Time frame: 8 weeks
1 secondary outcome
quantitative sensory testing (QST) accuracy in testing the inguinal region
Time frame: 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 19 Aug 2011.
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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.
J.F. Lange, professor principal investigator
Erasmus Medical Center
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 pregabalin in people with Chronic Pain, run by Erasmus Medical Center at 1 site in Netherlands.
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 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: finished, as of the sponsor's last update on 19 Aug 2011. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
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?
pain (time frame: 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 19 Aug 2011.