We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sb-705498 Rectal Pain Study

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00461682
First Posted: April 18, 2007
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: March 27, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Primary Purpose: Treatment
Condition: Irritable Colon
Intervention: Drug: SB-705498

  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
This study was conducted from 26 January 2007 till 18 September 2007. A total of 21 participants with irritable bowel syndrome (IBS) were planned to be enrolled.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Due to difficulties with recruitment, only one participant was enrolled in the study; however the participant received only Placebo and not the study drug.

Reporting Groups
  Description
Total Population Eligible participants were planned to receive oral SB-705498 eight hundred (800) milligrams (mg) once daily or matching Placebo in a randomized manner over two treatment periods once in the study. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.

Participant Flow:   Overall Study
    Total Population
STARTED   1 
COMPLETED   0 
NOT COMPLETED   1 
Protocol Violation                1 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Safety population included all participants who received at least one dose of the study drug.

Reporting Groups
  Description
Overall Study Arm No text entered.

Baseline Measures
   Overall Study Arm 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 
Years   21 [1] 
[1] Data not reported
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      1 100.0% 
Male      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
 
White/Caucasian/European Heritage   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Visual Analogue Scale (VAS) Pain Score to Rectal Distensions at Pre-dose and up to 6 Hours (h) Post-dose of Each Treatment Period   [ Time Frame: Baseline (Pre-dose) and up to 6 hours post-dose of each treatment period ]

2.  Secondary:   Visual Analogue Scores for Rectal Distensions for Gas, Urgency to Defecate and Discomfort at Pre-dose and 6 h Post-dose of Each Treatment Period   [ Time Frame: Baseline (pre-dose) and up to 6 h post-dose of each treatment period ]

3.  Secondary:   Rectal Sensory Thresholds to Thermal Stimulation (Contact Heat Device, Values Reported as in Study) at Pre-dose and 6h Post-dose of Each Treatment Period   [ Time Frame: Baseline (pre-dose) and 6h post-dose of each treatment period ]

4.  Secondary:   Peak Pain Intensity Difference (PPID6), as Derived From Maximum Pain Intensity (NRS) Difference From Baseline (Pre-dose on Day 1) by Single Measurement Recorded Over 0-6h of Each Treatment Period   [ Time Frame: Baseline (pre-dose) and up to 0-6 h of each treatment period ]

5.  Secondary:   Pain Intensity Difference (SPID6), as Derived From Pain Intensity (NRS) Difference From Baseline (Pre-dose on Day 1) by Single Measurement Recorded Over 0-6h Post-dose of Each Treatment Period   [ Time Frame: Baseline (pre-dose) and up to 0-6 h post-dose of each treatment period ]

6.  Secondary:   Somatic Heat Pain Thresholds (Hand and Foot) Assessed Pre-dose and 6h Post-dose of Each Treatment Period   [ Time Frame: Baseline (pre-dose) and upto 0-6h post-dose for each treatment period ]

7.  Secondary:   Contact Heat-evoked Potentials (CHEPs) – Optional, Assessed Pre-dose and 6h Post-dose of Each Treatment Period   [ Time Frame: Baseline (pre-dose) and 6h post-dose of each treatment period ]

8.  Secondary:   Number of Defecations Over 24h and Over 1 Week Following a Dose of SB-705498 (Monitored Using Bristol Stool Scoring Diary Kept 1 Week Pre- and 1 Week Post-dose)   [ Time Frame: 7 days pre-dose and 7 days post-dose of each treatment period ]

9.  Secondary:   Irritable Bowel Syndrome Symptom Severity Score (IBS SSS) Calculated Over Approximately 10 Days Pre- and Post-dose   [ Time Frame: 10 days pre-dose and post-dose of each treatment period ]

10.  Secondary:   Symptom Scoring and Quality of Life Assessments Over Period   [ Time Frame: Approximately up to 3 months ]

11.  Secondary:   Average Daily Pain Scores at Baseline (Pre-dose), 1, 2, 3, 4, 5 and 6h Post-dose for Each Treatment Period   [ Time Frame: At Baseline (pre-dose) and each hour post-dose of each treatment period ]


  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
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00461682     History of Changes
Other Study ID Numbers: VRA107438
First Submitted: April 17, 2007
First Posted: April 18, 2007
Results First Submitted: March 27, 2017
Results First Posted: May 8, 2017
Last Update Posted: May 8, 2017