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Trial record 82 of 399 for:    sodium phosphate

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

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ClinicalTrials.gov Identifier: NCT00696618
Recruitment Status : Completed
First Posted : June 13, 2008
Results First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Johns Hopkins University

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
Enrollment 9
Recruitment Details 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 Seventeen subjects were recruited. Eight individuals did not meet screening criteria and were not enrolled.
Arm/Group Title Tap Water/Normosol-R/Fleet Normosol-R/Fleet/Tap Water Fleet/Tap Water/Normosol-R
Hide Arm/Group Description

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 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 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

Period Title: Overall Study
Started 3 3 3
Completed 3 3 3
Not Completed 0 0 0
Arm/Group Title Tap Water/Normosol-R/Fleet Normosol-R/Fleet/Tap Water Fleet/Tap Water/Normosol-R Total
Hide Arm/Group Description

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 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 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 of all reporting groups
Overall Number of Baseline Participants 3 3 3 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 9 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 3 participants 9 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%
1.Primary Outcome
Title Mucosal Toxicity Using Histopathology
Hide Description

Endoscopy will be performed to obtain biopsy specimens at baseline and following each inpatient enema exposure. Samples will be obtained at each flexible sigmoidoscopy and set aside for batch sectioning and H&E staining. Slides will be reviewed and scored by a qualified pathologist blinded to treatment assignment using a qualitative scoring system. This scoring system uses semi-quantitative scoring that focuses on acute toxicity to epithelial cell layer similar to that seen in animal studies. This is a categorical grading scale, where 0 = Epithelial surface intact;1 = <1/3 of surface denuded; 2 = 1/3 - 2/3rds of surface denuded;3 = More than 2/3rds of surface denuded.

Six separate biopsies for each subject and each treatment intervention were analyzed in a multi-level analysis. In comparison with the baseline condition (no intervention), the odds and 95% confidence interval (CI) of having a higher epithelial denudation score were calculated for each intervention.

Time Frame One hour following enema exposure
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received one dose of each intervention and completed all study visits were included in the analysis.
Arm/Group Title Hypo-osmolar Enema Iso-osmolar Enema Hyper-osmolar Enema
Hide Arm/Group Description:
Hypo-osmolar Tap water enema
Normosol-R Iso-osmolar enema
Fleet Hyper-osmolar enema
Overall Number of Participants Analyzed 9 9 9
Overall Number of Units Analyzed
Type of Units Analyzed: Colon biopsies
54 54 54
Geometric Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.6
(0.2 to 1.7)
0.5
(0.2 to 1.5)
4.2
(1.7 to 10.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hypo-osmolar Enema, Iso-osmolar Enema, Hyper-osmolar Enema
Comments Nine research participants provided the ability to detect an effect size of 1.25 standard deviation units relative to the mean with 80% power using two-sided, 5% alpha in a paired analysis. The Baseline condition (no intervention) was assigned a value of 1 and geometric mean ratios with 95% confidence intervals for each intervention were calculated relative to baseline.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments Adjusted for multiple comparisons.
Method multi-level
Comments [Not Specified]
2.Secondary Outcome
Title Radiolabel Area Under the Curve (AUC 0-24 hr)
Hide Description Percent of radiolabel dose administered was determined by plasma sampling at standardized intervals over 24 hours. AUC was then calculated using the trapezoidal rule and reported as x10 log 7 microcurie-hours/mL
Time Frame 24 hours following each intervention
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received one dose of each intervention and completed all study visits were included in the analysis.
Arm/Group Title Hypo-osmolar Enema Iso-osmolar Enema Hyper-osmolar Enema
Hide Arm/Group Description:
Hypo-osmolar Tap water enema
Normosol-R Iso-osmolar enema
Fleet Hyper-osmolar enema
Overall Number of Participants Analyzed 9 9 9
Median (Inter-Quartile Range)
Unit of Measure: 10 log 7 microcurie-hours/mL
21.4
(17.4 to 44.9)
19.7
(8.4 to 27.4)
9.4
(8.7 to 13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hypo-osmolar Enema, Iso-osmolar Enema, Hyper-osmolar Enema
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method multi-level
Comments [Not Specified]
3.Secondary Outcome
Title D(Average) at Two Hours
Hide Description Mean proximal residence distance of radio-signal from anus as measured on SPECT/CT
Time Frame two hours following dosing of intervention
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received one dose of each intervention and completed all study visits were included in the analysis.
Arm/Group Title Hypo-osmolar Enema Iso-osmolar Enema Hyper-osmolar Enema
Hide Arm/Group Description:
Hypo-osmolar Tap water enema
Normosol-R Iso-osmolar enema
Fleet Hyper-osmolar enema
Overall Number of Participants Analyzed 9 9 9
Median (Inter-Quartile Range)
Unit of Measure: centimeters
8.6
(6.8 to 11.8)
20.6
(17.4 to 25.6)
7.7
(0 to 14.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hypo-osmolar Enema, Iso-osmolar Enema, Hyper-osmolar Enema
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.05
Comments [Not Specified]
Method mulit-level analysis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hypo-osmolar Enema Iso-osmolar Enema Hyper-osmolar Enema
Hide Arm/Group Description Hypo-osmolar Tap water enema Normosol-R Iso-osmolar enema Fleet Hyper-osmolar enema
All-Cause Mortality
Hypo-osmolar Enema Iso-osmolar Enema Hyper-osmolar Enema
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Hypo-osmolar Enema Iso-osmolar Enema Hyper-osmolar Enema
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/9 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Hypo-osmolar Enema Iso-osmolar Enema Hyper-osmolar Enema
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/9 (44.44%)      2/9 (22.22%)      3/9 (33.33%)    
Gastrointestinal disorders       
GI complaints other * [1]  1/9 (11.11%)  1 1/9 (11.11%)  1 2/9 (22.22%)  2
Investigations       
Procedure-related * [2]  4/9 (44.44%)  7 2/9 (22.22%)  3 3/9 (33.33%)  5
Nervous system disorders       
Dizzyness *  0/9 (0.00%)  0 0/9 (0.00%)  0 1/9 (11.11%)  1
Product Issues       
GI complaints thought related to study product * [3]  0/9 (0.00%)  0 1/9 (11.11%)  1 1/9 (11.11%)  1
Skin and subcutaneous tissue disorders       
Facial cut *  1/9 (11.11%)  1 0/9 (0.00%)  0 0/9 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Includes other GI disorders not believed to be related to study product (E.g. nausea/vomiting, diarrhea related to intercurrent illness)
[2]
adverse events secondary to study procedures, including musculoskeletal complaints from positioning in scanner, bloating/gas following endoscopy, hematoma from blood drawing.
[3]
Includes lower GI complaints such as rectal tenderness, anal canal irritation
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
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00696618     History of Changes
Other Study ID Numbers: NA_00010972
First Submitted: June 4, 2008
First Posted: June 13, 2008
Results First Submitted: December 5, 2016
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017