Chest PainPhase 4NCT00800527
Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
A Phase 4 study testing Gabapentin and Diclofenac in people with Chest Pain and Paresthesia, run by Usak State Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this study, the investigators aim to demonstrate the efficacy of gabapentin compared with diclofenac in the treatment of chronic non-ischemic chest pain and paresthesia of the patients with sternotomy and to elucidate the similarities of PCPP to neuropathic pain syndromes. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Chest Pain, Paresthesia
- What is being tested?
- Gabapentin and Diclofenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2007to Oct 2008
- 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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Poststernotomy chest pain and/or paresthesia
Who cannot join
- Osteoporosis, renal function impairment (creatinine value >1.5 mg / dl.)
- Hepatic dysfunction, peptic ulcer, chest pain with ischemic origin, pediatric cases
- Over production of scar tissue, thoracic surgery other than sternotomy -
- Redo-bypass surgery, infection, sternal dehiscence,valve surgery together with bypass
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
In this study, the investigators aim to demonstrate the efficacy of gabapentin compared with diclofenac in the treatment of chronic non-ischemic chest pain and paresthesia of the patients with sternotomy and to elucidate the similarities of PCPP to neuropathic pain syndromes.
Read the detailed description
Because the primary objective of this study is to evaluate the effect of different drugs on chest pain and paresthesia, we choose the prospective, randomized, open label, blinded end point design for this study. According to this design, both patients and physicians making first assessment are aware of the treatment but the investigators making second and third assessment are blinded to treatment. Therefore, two separate cardiovascular surgeons wil select and randomize the patients and a cardiologist blinded to treatment assignments will evaluate the patients at second interview at thirty day and 3 months later. The study was approved by the Local Ethics Committee and informed consent was obtained from each patient. The study was conducted in Usak State Hospital with collaboration the Department of Cardiology of Ataturk Education and Training Hospital.
- Conditions
- Chest Pain, Paresthesia
- Being tested
- Gabapentin, Diclofenac
- Keywords
- sternotomy, pain, paresthesia, Poststernotomy chest pain, Poststernotomy chest paresthesia
- Medical subject headings
- Chest Pain, Paresthesia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Group-1: Gabapentin Arm
Gabapentin 800 mg one a day up to 30 day
DiclofenacDrug
Also called Group-2: Diclofenac arm
Diclofenac 75 mg one a day up to 30 day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Gabapentin Receives: Drug: Gabapentin |
| 2 | Active comparator | Diclofenac Receives: Drug: Diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pain or paresthesia severity
Measured: one month
Secondary outcomes (1)
duration of relief of pain or paresthesia
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startNov 2007
- Primary completionJun 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Usak State Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ismail BIYIK, MD, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800527
- Sponsor's protocol ID
- B4ISM4350015-009/295
- Status last verified
- Nov 2008
- First submitted
- 28 Nov 2008
- Last updated
- 2 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Efficacy of Gabapentin in the Treatment of Chest Pain and Paresthesia in Patients With Sternotomy
- ClinicalTrials.gov ID
- NCT00800527
- Acronym / sponsor ID
- B4ISM4350015-009/295
- Conditions
- Chest Pain, Paresthesia
- Keywords
- sternotomy, pain, paresthesia, Poststernotomy chest pain, Poststernotomy chest paresthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Usak State HospitalUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 2 Dec 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.
In this study, the investigators aim to demonstrate the efficacy of gabapentin compared with diclofenac in the treatment of chronic non-ischemic chest pain and paresthesia of the patients with sternotomy and to elucidate the similarities of PCPP to neuropathic pain syndromes.
Detailed description
Because the primary objective of this study is to evaluate the effect of different drugs on chest pain and paresthesia, we choose the prospective, randomized, open label, blinded end point design for this study. According to this design, both patients and physicians making first assessment are aware of the treatment but the investigators making second and third assessment are blinded to treatment. Therefore, two separate cardiovascular surgeons wil select and randomize the patients and a cardiologist blinded to treatment assignments will evaluate the patients at second interview at thirty day and 3 months later. The study was approved by the Local Ethics Committee and informed consent was obtained from each patient. The study was conducted in Usak State Hospital with collaboration the Department of Cardiology of Ataturk Education and Training Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: GabapentinGabapentin |
| 2 | Active comparator | Drug: DiclofenacDiclofenac |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Poststernotomy chest pain and/or paresthesia
Key exclusion criteria (4 listed)
- Osteoporosis, renal function impairment (creatinine value >1.5 mg / dl.)
- Hepatic dysfunction, peptic ulcer, chest pain with ischemic origin, pediatric cases
- Over production of scar tissue, thoracic surgery other than sternotomy -
- Redo-bypass surgery, infection, sternal dehiscence,valve surgery together with bypass
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 |
|---|---|---|
| GabapentinAlso: Group-1: Gabapentin ArmGabapentin 800 mg one a day up to 30 day | Drug | 1 |
| DiclofenacAlso: Group-2: Diclofenac armDiclofenac 75 mg one a day up to 30 day | Drug | 2 |
Primary outcome
Reduction of pain or paresthesia severity
Time frame: one month
1 secondary outcome
duration of relief of pain or paresthesia
Time frame: three month
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 2 Dec 2008.
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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.
Ismail BIYIK, MD principal investigator
Investigator
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 and Diclofenac in people with Chest Pain and Paresthesia, run by Usak State Hospital at 1 site in Turkey (Türkiye).
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 4 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 2 Dec 2008. 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 Turkey (Türkiye). 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?
Reduction of pain or paresthesia severity (time frame: one month). 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 2 Dec 2008.