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Enema Use and Acceptability in HIV Negative Men Who Have Sex With Men

This study has been completed.
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00696618
First received: June 4, 2008
Last updated: March 20, 2017
Last verified: March 2017
Results First Received: December 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: HIV Infections
Interventions: Drug: Fleet Enema
Drug: tap water enema
Drug: Normosol-R enema

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study participants were recruited to the outpatient clinical unit via a volunteer screening database.Similarly, individuals may have responded to advertisements posted throughout the Johns Hopkins Medical Institutions or via word of mouth from other research participants. Individuals were recruited between 10/10/07 and 01/06/09.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Seventeen subjects were recruited. Eight individuals did not meet screening criteria and were not enrolled.

Reporting Groups
  Description
Tap Water/Normosol-R/Fleet

Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home(Stage 2), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)

Fleet Enema: hyper-osmolar preparation

tap water enema: hypo-osmolar preparation

Normosol-R enema: iso-osmolar preparation

Normosol-R/Fleet/Tap Water

Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)

Fleet Enema: hyper-osmolar preparation

tap water enema: hypo-osmolar preparation

Normosol-R enema: iso-osmolar preparation

Fleet/Tap Water/Normosol-R

Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Normosol-R enema(iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)

Fleet Enema: hyper-osmolar preparation

tap water enema: hypo-osmolar preparation

Normosol-R enema: iso-osmolar preparation


Participant Flow:   Overall Study
    Tap Water/Normosol-R/Fleet   Normosol-R/Fleet/Tap Water   Fleet/Tap Water/Normosol-R
STARTED   3   3   3 
COMPLETED   3   3   3 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tap Water/Normosol-R/Fleet

Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home(Stage 2), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)

Fleet Enema: hyper-osmolar preparation

tap water enema: hypo-osmolar preparation

Normosol-R enema: iso-osmolar preparation

Normosol-R/Fleet/Tap Water

Normosol-R enema (iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)

Fleet Enema: hyper-osmolar preparation

tap water enema: hypo-osmolar preparation

Normosol-R enema: iso-osmolar preparation

Fleet/Tap Water/Normosol-R

Fleet enema (hyper-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 1), Followed by Tap water enema (hypo-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 2), Followed by Normosol-R enema(iso-osmolar) administered rectally 125 mL one time in the clinic, then self-administered on three separate occasions at home (Stage 3)

Fleet Enema: hyper-osmolar preparation

tap water enema: hypo-osmolar preparation

Normosol-R enema: iso-osmolar preparation

Total Total of all reporting groups

Baseline Measures
   Tap Water/Normosol-R/Fleet   Normosol-R/Fleet/Tap Water   Fleet/Tap Water/Normosol-R   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   3   3   9 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      3 100.0%      3 100.0%      3 100.0%      9 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      3 100.0%      3 100.0%      3 100.0%      9 100.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mucosal Toxicity Using Histopathology   [ Time Frame: One hour following enema exposure ]

2.  Secondary:   Radiolabel Area Under the Curve (AUC 0-24 hr)   [ Time Frame: 24 hours following each intervention ]

3.  Secondary:   D(Average) at Two Hours   [ Time Frame: two hours following dosing of intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Associate Director, Drug Development Unit
Organization: Johns Hopkins School of Medicine
phone: (410)641-8762
e-mail: ejfuchs@jhmi.edu



Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00696618     History of Changes
Other Study ID Numbers: NA_00010972
Study First Received: June 4, 2008
Results First Received: December 5, 2016
Last Updated: March 20, 2017