Refractive ErrorsPhase 1PRKNCT01122004
The Effect of Gabapentin (Neurentin) and Pregabalin (Lyrica) in Pain Reduction After Photorefractive Keratectomy
A Phase 1 study testing Pregabalin in people with Refractive Errors, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
The studied patients will be given randomly one of three following drugs1:Gabapentin2: Pregabalin or placebo for 3 days after Photorefractive keratectomy surgery. The pain will be measured based on visual analog scale(VAS) on the day of operation and on the 3 rd day (morning, evening) and then compared among three… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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 17 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- patients candidate for PRK, 17<age<70
Who cannot join
- use of any systemic analgesic drugs, drug intolerance, need of systemic or topical administration of NSAIDs or eye drops for allergy and glaucoma, dry eyes, pregnancy, breast feeding
Trial locations and contacts
1 site in 1 country.
Amir faramarzi, MD contact
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran, Tehran Province, 166666
Amir Faramarzi, MD, labbafi@hotmail.com
About this study
The studied patients will be given randomly one of three following drugs1:Gabapentin2: Pregabalin or placebo for 3 days after Photorefractive keratectomy surgery. The pain will be measured based on visual analog scale(VAS) on the day of operation and on the 3 rd day (morning, evening) and then compared among three groups.
- Conditions
- Refractive Errors
- Being tested
- Pregabalin
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
PregabalinDrug
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Active comparator | Not described Receives: Drug: Pregabalin |
| 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 degree based on visual analog scale(VAS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122004
- Sponsor's protocol ID
- 8877
- Acronym
- PRK
- Status last verified
- Mar 2010
- First submitted
- 12 Apr 2010
- Last updated
- 12 May 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gabapentin (Neurentin) and Pregabalin (Lyrica) in Pain Reduction After Photorefractive Keratectomy
- ClinicalTrials.gov ID
- NCT01122004
- Acronym / sponsor ID
- PRK / 8877
- Conditions
- Refractive Errors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- First posted
- 12 May 2010 (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.
The studied patients will be given randomly one of three following drugs1:Gabapentin2: Pregabalin or placebo for 3 days after Photorefractive keratectomy surgery. The pain will be measured based on visual analog scale(VAS) on the day of operation and on the 3 rd day (morning, evening) and then compared among three groups.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Active comparator | Drug: Pregabalin |
| Pregabalin | Active comparator | Drug: Pregabalin |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients candidate for PRK, 17<age<70
Key exclusion criteria (1 listed)
- use of any systemic analgesic drugs, drug intolerance, need of systemic or topical administration of NSAIDs or eye drops for allergy and glaucoma, dry eyes, pregnancy, breast feeding
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 |
|---|---|---|
| Pregabalin | Drug | Gabapentin |
| Pregabalin | Drug | Pregabalin |
Primary outcome
pain degree based on visual analog scale(VAS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
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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.
Amir faramarzi, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pregabalin in people with Refractive Errors, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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: status not confirmed, as of the sponsor's last update on 12 May 2010. 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 Iran. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Amir faramarzi, MD (+982122585952), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain degree based on visual analog scale(VAS). 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 12 May 2010.