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
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