A Phase 1 interventional study of fesoterodine fumarate and placebo in Healthy, sponsored by Pfizer. Terminated at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-24.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
To assess the effect of fesoterodine 8 mg as compared to solifenacin 10 mg on colonic transit.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tablets
Drug: fesoterodine fumarate
Tablets
Drug: placebo
Tablets
Drug: solifenacin
8 mg OD for 14 days
OD for 14 days
10 mg OD for 14 days
Colonic Transit at 24 Hours
Colonic transit: Geometric centre at 24 hours (GC24) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC \*1 + % TC \*2 + % DC \*3 + % RS \*4 + % stool \* 5 ) divided by 100.
Time frame: Day 13 (Day 12 24 hours post-meal)
Proximal Colonic Emptying Time
Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.
Time frame: Day 12 to 14
Colonic Transit at 48 Hours
Colonic transit: Geometric centre at 48 hours (GC48) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC \*1 + % TC \*2 + % DC \*3 + % RS \*4 + % stool \* 5 ) divided by 100.
Time frame: Day 14 (Day 12 48 hours post-meal)
Colonic Filling at 6 Hours
A surrogate marker of small bowel transit time.
Time frame: Day 12
Time to Gastric Emptying
Ascending colon emptying t½ was estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.
Time frame: Day 12: 2 hours, 4 hours
Mean Number of Stools Per Day
Number of stools passed on each notional day where each visit to the toilet counts as one stool (only) unless nothing is passed. Mean of 3 days.
Time frame: Day 11 to 13
Mean Score of Stool Consistency Per Day
Calculated by averaging the values of the stool form given at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (hard lumps) to 7 (watery).
Time frame: Day 11 to 13
Average Score of Ease of Passage During Defecation Per Day
Calculated by averaging the values given for the ease of passage at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (Manual disimpaction) to 7 (Incontinent).
Time frame: Day 11 to 13
Mean Proportion of Bowel Movements With Satisfaction Per Day
The number of stools with satisfaction of "Yes" divided by the total number of stools passed on each notional day. Mean of 3 days.
Time frame: Day 11 to 13
| Milestone | Fesoterodine | Placebo | Solifenacin |
|---|---|---|---|
| Started | 25 | 12 | 23 |
| Treated | 25 | 12 | 22 |
| Completed | 25 | 12 | 22 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Randomized but not treated | 0 | 0 | 1 |
Colonic transit: Geometric centre at 24 hours (GC24) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC \*1 + % TC \*2 + % DC \*3 + % RS \*4 + % stool \* 5 ) divided by 100.
| counts | Fesoterodine | Placebo | Solifenacin |
|---|---|---|---|
| Colonic Transit at 24 Hours | 1.98 ± 0.770 | 2.51 ± 1.078 | 1.91 ± 0.515 |
Estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.
| hours | Fesoterodine | Placebo | Solifenacin |
|---|---|---|---|
| Proximal Colonic Emptying Time | 21.06 ± 5.500 | 14.79 ± 6.239 | 19.23 ± 6.194 |
Colonic transit: Geometric centre at 48 hours (GC48) was estimated using geometric mean of counts in ascending (AC), transverse (TC), descending (DC) and rectosigmoid (RS) colon and stool (weighted by factors of 1 to 5 respectively). To calculate the geometric centre, the proportion of colonic counts in each colonic region was multiplied by its weighing factor: (% AC \*1 + % TC \*2 + % DC \*3 + % RS \*4 + % stool \* 5 ) divided by 100.
| counts | Fesoterodine | Placebo | Solifenacin |
|---|---|---|---|
| Colonic Transit at 48 Hours | 3.55 ± 0.934 | 3.67 ± 1.066 | 3.14 ± 0.765 |
A surrogate marker of small bowel transit time.
| percentage | Fesoterodine | Placebo | Solifenacin |
|---|---|---|---|
| Colonic Filling at 6 Hours | 7.84 ± 16.286 | 69.58 ± 25.854 | 24.06 ± 23.696 |
Ascending colon emptying t½ was estimated by power exponential analysis of the proportionate emptying over time of counts from the colon.
| minutes | Fesoterodine | Placebo | Solifenacin |
|---|---|---|---|
| Time to Gastric Emptying | 145.00 ± 32.628 | 112.92 ± 21.998 | 127.47 ± 35.456 |
Number of stools passed on each notional day where each visit to the toilet counts as one stool (only) unless nothing is passed. Mean of 3 days.
| stools | Fesoterodine | Placebo | Solifenacin |
|---|---|---|---|
| Mean Number of Stools Per Day | 0.93 ± 0.397 | 1.06 ± 0.422 | 1.11 ± 0.497 |
Calculated by averaging the values of the stool form given at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (hard lumps) to 7 (watery).
| score on a scale | Fesoterodine | Placebo | Solifenacin |
|---|---|---|---|
| Mean Score of Stool Consistency Per Day | 3.66 ± 1.149 | 3.29 ± 1.112 | 3.02 ± 1.057 |
Calculated by averaging the values given for the ease of passage at each visit to the toilet on each notional day. Mean of 3 days. Range of possible scores: 1 (Manual disimpaction) to 7 (Incontinent).
| score on a scale | Fesoterodine | Placebo | Solifenacin |
|---|---|---|---|
| Average Score of Ease of Passage During Defecation Per Day | 3.90 ± 0.403 | 3.97 ± 0.096 | 3.83 ± 0.705 |
The number of stools with satisfaction of "Yes" divided by the total number of stools passed on each notional day. Mean of 3 days.
| mean proportion | Fesoterodine | Placebo | Solifenacin |
|---|---|---|---|
| Mean Proportion of Bowel Movements With Satisfaction Per Day | 0.88 ± 0.250 | 0.81 ± 0.324 | 0.93 ± 0.234 |
Collected over Up to 7 days after last dose of study drug. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fesoterodine | — | 0/25 (0%) | 22/25 (88%) |
| Placebo | — | 0/12 (0%) | 6/12 (50%) |
| Solifenacin | — | 0/22 (0%) | 15/22 (68.2%) |
| Event | Fesoterodine | Placebo | Solifenacin |
|---|---|---|---|
| Dry mouthGastrointestinal disorders | 13/25 | 0/12 | 7/22 |
| HeadacheNervous system disorders | 12/25 | 3/12 | 2/22 |
| Abdominal pain upperGastrointestinal disorders | 0/25 | 3/12 | 1/22 |
| DyspepsiaGastrointestinal disorders | 1/25 | 3/12 | 0/22 |
| Abdominal distensionGastrointestinal disorders | 0/25 | 0/12 | 3/22 |
| Back painMusculoskeletal and connective tissue disorders | 0/25 | 0/12 | 3/22 |
| DysmenorrhoeaReproductive system and breast disorders | 2/25 | 1/12 | 3/22 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 1/25 | 0/12 | 3/22 |
| Abdominal discomfortGastrointestinal disorders | 1/25 | 1/12 | 2/22 |
| Abdominal painGastrointestinal disorders | 2/25 | 0/12 | 2/22 |
| Age, Customized(participants) | Fesoterodine | Placebo | Solifenacin | Total |
|---|---|---|---|---|
| less than 18 years | 0 | 0 | 0 | 0 |
| 18 to 25 years | 5 | 5 | 6 | 16 |
| 26 to 35 years | 7 | 2 | 6 | 15 |
| 36 to 45 years | 7 | 2 | 8 | 17 |
| greater than 45 years | 6 | 3 | 3 | 12 |
| Sex: Female, Male(Participants) | Fesoterodine | Placebo | Solifenacin | Total |
|---|---|---|---|---|
| Female | 25 | 12 | 23 | 60 |
| Male | 0 | 0 | 0 | 0 |
This study is terminated, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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