BlindnessPhase 4NCT00251784
Healthy Volunteer Study of Sildenafil Effects Upon Vision
A Phase 4 study testing Sildenafil in people with Blindness, run by University of Cambridge.
Trial summary
Patients sometimes report subjective visual effects when taking sildenafil. Our study set out to measure these in a controlled setting. Subjects were asked to detect patterns presented on a monitor screen. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Blindness
- What is being tested?
- Sildenafil
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Feb 2002to Jun 2003
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
About this study
Official title: A Double-Blind, Randomised, Placebo Controlled Healthy Volunteer Study to Investigate the Nature and Origin of the Disturbance of Vision Induced by Single Oral Doses of Sildenafil
Patients sometimes report subjective visual effects when taking sildenafil. Our study set out to measure these in a controlled setting. Subjects were asked to detect patterns presented on a monitor screen.
- Conditions
- Blindness
- Being tested
- Sildenafil
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startFeb 2002
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlindnessStudies 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
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Investigators
- Morris J Brown, MD, Principal investigator, University of CambridgeJohn Mollon, FRS, Study director, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251784
- Sponsor's protocol ID
- LREC 98/297
- Status last verified
- Dec 2003
- First submitted
- 9 Nov 2005
- Last updated
- 10 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomised, Placebo Controlled Healthy Volunteer Study to Investigate the Nature and Origin of the Disturbance of Vision Induced by Single Oral Doses of Sildenafil
- ClinicalTrials.gov ID
- NCT00251784
- Acronym / sponsor ID
- LREC 98/297
- Conditions
- Blindness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Study start
- Feb 2002
- Study completion
- Jun 2003
- First posted
- 10 Nov 2005 (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.
Patients sometimes report subjective visual effects when taking sildenafil. Our study set out to measure these in a controlled setting. Subjects were asked to detect patterns presented on a monitor screen.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Sildenafil | Drug | – |
Primary outcome
Not reported in the source record.
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 10 Nov 2005.
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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.
Morris J Brown, MD principal investigator
University of Cambridge
John Mollon, FRS study director
University of Cambridge
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sildenafil in people with Blindness, run by University of Cambridge.
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 0 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 10 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
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.
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 10 Nov 2005.