Trial Outcomes & Findings for Sb-705498 Rectal Pain Study (NCT NCT00461682)

Results Overview

This analysis was performed at 12, 24, 36 and 48 millimeters of mercury (mmHg) which was above the baseline operating pressure threshold. Participants assessed the cough severity and urge to cough using VAS immediately prior to capsaicin challenge. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Average of Day -1 and pre-dose was planned as Baseline for VAs assessment. The VAS score was planned to be analyzed on Day-1, Day 1, 2 hours, and 24 hours. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents "No pain" and 10 represents "Worst pain imaginable" was planned to be used for the subjective assessment of the pain.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Baseline (Pre-dose) and up to 6 hours post-dose of each treatment period

Results posted on

2018-08-20

Participant Flow

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.

Due to difficulties with recruitment, only one participant was enrolled in the study; however the participant received only Placebo and not the study drug.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Protocol Violation	1

Baseline Characteristics

Sb-705498 Rectal Pain Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Arm n=1 Participants
Age, Continuous Years	21 Years STANDARD_DEVIATION NA • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian/European Heritage	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Pre-dose) and up to 6 hours post-dose of each treatment period

This analysis was performed at 12, 24, 36 and 48 millimeters of mercury (mmHg) which was above the baseline operating pressure threshold. Participants assessed the cough severity and urge to cough using VAS immediately prior to capsaicin challenge. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Average of Day -1 and pre-dose was planned as Baseline for VAs assessment. The VAS score was planned to be analyzed on Day-1, Day 1, 2 hours, and 24 hours. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents "No pain" and 10 represents "Worst pain imaginable" was planned to be used for the subjective assessment of the pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-dose) and up to 6 h post-dose of each treatment period

The VAS scores for assessment of rectal sensation for pain, gas, urgency and discomfort were analyzed separately. Participants assessed the cough severity and urge to cough using VAS immediately prior to capsaicin challenge. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Average of Day -1 and pre-dose was planned as Baseline for VAs assessment. The VAS score was planned to be analyzed on Day-1, Day 1, 2 hours, and 24 hours. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents "No pain" and 10 represents "Worst pain imaginable" was planned to be used for the subjective assessment of the pain. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-dose) and 6h post-dose of each treatment period

Visceral hypersensitivity is defined as reduced pain and discomfort threshold to rectal stimuli. Rectal hypersensitivity was correlated with the degree of rectal hypersensitivity (up-regulation of TRPV-1 receptors) as measured by rectal thermal stimulation. Ongoing rectal pain intensity scale is 11-point numeric rating scale, where 0=Unnoticeable/No Pain, 10=Unbearable/Worst Pain. An average of daily scores over 1 week pre-dose and 1 week post-dose was recorded. Single measurements pre-dose and at hourly intervals within 6 hours post-dose were also recorded. Participants were planned to stay in the hospital for 6h post-dose and were planned to be discharged when physician was satisfied with their medical condition. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Participants assessed the cough severity and urge to cough using VAS immediately prior to capsaicin challenge.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-dose) and up to 0-6 h of each treatment period

No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant. Change from Baseline (pre-dose) is the value at indicated time-point minus the Baseline value. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents "No pain" and 10 represents "Worst pain imaginable" was planned to be used for the subjective assessment of the pain.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-dose) and up to 0-6 h post-dose of each treatment period

Change from Baseline (pre-dose0 is the value at indicated time point minus the Baseline value. Average daily pain scores as captured in participant diary cards were planned to be summarized descriptively and planned to be analyzed. The 11 point pain intensity numerical rating scale ranging from 0 to 10, where 0 represents "No pain" and 10 represents "Worst pain imaginable" was planned to be used for the subjective assessment of the pain. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-dose) and upto 0-6h post-dose for each treatment period

Evoked potentials were to be recorded from midline electrodes by placing a ground electrode on temporal lobe region. A low cut off filter with a time constant of 1.06103 and a frequency of 0.15 hertz (Hz) and a high cut off filter of 100Hz was to be applied. The impedance from all electrodes was maintained below 5 ohms (Ω) and the electroencephalogram (EEG) was recorded, digitized at a sampling rate of 500 Hz. Responses from ten stimuli were to be recorded from each participant with the thermode placed over foot and one hand (non-dominant side). The thermode heating rate was set at 70 degree Celsius per second (°C/s) and the cooling rate at 40°C/s. The baseline temperature was 32 °C, destination temperature 51 °C, and stimulus interval approximately of 7 seconds. The participants were allowed to withdraw any time. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (pre-dose) and 6h post-dose of each treatment period

For heat pain threshold measurement, temperature of the thermode was gradually increased from the baseline (32°C) at a rate of 1°C/s. The ramp was stopped and the temperature of the thermode was returned to the Baseline. This was repeated three times. The threshold temperatures and the average value were recorded by the computer. If the thermode temperature reached 50°C without the participant responding, the ramp was stopped and the temperature was returned to baseline automatically to prevent skin injury. This test was performed within two minutes. The respective cut-off temperature is then recorded for that trial. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 days pre-dose and 7 days post-dose of each treatment period

Onset associated with change in the frequency and change in the appearance of stools, abnormal stool frequency (\>3/day or \< 3/week); abnormal stool form (lumpy/hard or loose/watery stool), abnormal stool passage (straining, urgency, or feeling of incomplete evacuation); passage of mucus, and bloating were analyzed over period. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 10 days pre-dose and post-dose of each treatment period

Participants were rated on a scale based on following parameters - Onset associated with change in the frequency and change in the appearance of stools, abnormal stool frequency (\>3/day or \< 3/week); abnormal stool form (lumpy/hard or loose/watery stool), abnormal stool passage (straining, urgency, or feeling of incomplete evacuation); passage of mucus, and bloating were analyzed over period. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately up to 3 months

Different scales used in this study included HAD, BDI, SF36, Bristol Stool Scoring, IBS QOL and SSS that were used to rate different scores on respective scales. Untreated pain leads to a decrease in daily function capability, social stresses, loss of work, an overall poor quality of life and a burden on healthcare resources. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At Baseline (pre-dose) and each hour post-dose of each treatment period

Individual pain scores were collected at screening and pre and post dose during the anorectal physiological assessments. Average daily pain scores as captured in participants' diary cards were summarized descriptively and analyzed. The 11 point pain intensity numerical rating scale ranges from 0 to 10, where 0 represents "No pain" and 10 represents "Worst pain imaginable". This was used for the subjective assessment of the pain over period. No results were reported since the study objectives were not met due to the early study termination and withdrawal of participant.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

SB-705498

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=1 participants at risk Eligible participants received matching Placebo during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the Placebo.	SB-705498 n=1 participants at risk Participants were planned to receive oral SB-705498 800 milligrams (mg) once daily in a randomized manner during either of the two treatment periods. All participants were planned to be followed-up maximum up to 28 days after the last dose of the study drug.
Gastrointestinal disorders Abdominal (iliac fossa) pain	100.0% 1/1 • Approximately up to 3 months Safety population included all participants who received at least one dose of the study drug. Due to early termination of the study, only 1 participant was recruited in the study who had one SAE (19 days post placebo) and 0 non-serious AE's is reported.	0.00% 0/1 • Approximately up to 3 months Safety population included all participants who received at least one dose of the study drug. Due to early termination of the study, only 1 participant was recruited in the study who had one SAE (19 days post placebo) and 0 non-serious AE's is reported.

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER