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A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00439868
First received: February 22, 2007
Last updated: August 9, 2017
Last verified: August 2017
February 22, 2007
August 9, 2017
February 16, 2007
June 8, 2007   (Final data collection date for primary outcome measure)
Intraocular pressure at Day -1, Days 1 & 14. [ Time Frame: at Day -1, Days 1 & 14. ]
Intraocular pressure at Day -1, Days 1 & 14.
Complete list of historical versions of study NCT00439868 on ClinicalTrials.gov Archive Site
  • Intraocular pressure,Pupil diameter, anterior chamber angle [ Time Frame: Days-1,1&14 ]
  • Wellbutrin XL plasma level [ Time Frame: Days1,12-14 ]
  • adverse events [ Time Frame: each visit ]
  • lab tests,ECG,vital signs: [ Time Frame: screening,followup ]
  • lab tests: [ Time Frame: Days-2,13-14 ]
  • ECG: [ Time Frame: Day 14 ]
  • vital signs: [ Time Frame: Days-2,-1,1,14 ]
Intraocular pressure,Pupil diameter, anterior chamber angle:Days-1,1&14 Wellbutrin XL plasma level:Days1,12-14 adverse events:each visit lab tests,ECG,vital signs:screening,followup lab tests:Days-2,13-14 ECG:Day 14 vital signs:Days-2,-1,1,14
Not Provided
Not Provided
 
A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure
A Cross-over Study to Evaluate the Effect of WELLBUTRIN XL on Intraocular Pressure in Healthy Volunteers
This study will be conducted in healthy volunteers to investigate the effect on intraocular pressure of 2 weeks of treatment with 300mg WELLBUTRIN XL/day.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Diagnostic
Depressive Disorder
  • Drug: WellbutrinXL
    WELLBUTRIN XL tablets will be available with dose strength of 150 and 300 mg.
  • Drug: placebo
    Matching placebo tablets to WELLBUTRIN XL.
    Other Name: WellbutrinXL
  • Experimental: Treatment Group 1
    Subjects in Period 1 of treatment group 1 will receive oral doses of extended release WELLBUTRIN XL tablets for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD. In Period 2 subject will receive placebo for 2 weeks.
    Interventions:
    • Drug: WellbutrinXL
    • Drug: placebo
  • Experimental: Treatment Group 2
    Subjects in Period 1 of Treatment group 2 will receive Placebo for 2 weeks and in Period 2 subject will receive oral doses of extended release WELLBUTRIN XL for 2 weeks, from Days 1-3 subject will receive 150 milligram (mg) tablets once daily (QD) and from Days 4-14 300 mg QD.
    Interventions:
    • Drug: WellbutrinXL
    • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
June 8, 2007
June 8, 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy males or females.
  • Non-smokers
  • Agree to remain in the clinic for the time defined in the protocol.
  • Normal ECG.

Exclusion Criteria:

  • Any serious medical disorder or condition.
  • Any history of an endocrine disorder.
  • Any clinically significant laboratory abnormality.
  • History of psychiatric illness.
  • Any history of suicidal attempts or behavior.
  • Risk factors for precipitation of angle closure glaucoma or elevated IOP.
  • Inability to refrain from use of contact lenses during the study days, if correction is required.
  • Self-administered Beck Depression Inventory II scale total score greater than 9, and a suicide question score of greater than zero.
  • Current or past history of seizure disorder or brain injury (traumatic or disease-related); or any condition which, in the opinion of the investigator, predisposes to seizure - Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00439868
WXL108709
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP