Primary outcomeMean· Baseline, Week 4
Change From Baseline in Abdominal Girth at Week 4
| Group | Value (cm) | Spread |
|---|---|---|
| Matching Placebo | 82.6 | 11.8 |
| 290 μg Linaclotide | 83.7 | 9.02 |
Trial · Interventional
TerminatedPhase 4Results postedRegistry dataA Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)
NCTNCT02837783 (opens ClinicalTrials.gov in a new tab)Other idMCP-103-403
This trial was stopped early.
Reason given at the registry: Insufficient enrollment
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 4
- Enrollment
- 20 participants (actual)
- Sponsor
- Ironwood Pharmaceuticals, Inc. · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
United Kingdom
- Start
- 21 Dec 2016
- Primary completion
- 31 Oct 2018
- Completion
- 31 Oct 2018
- First posted
- 20 Jul 2016 (estimated)
- Last update posted
- 6 Dec 2021
- Conditions
- Irritable Bowel Syndrome Characterized by Constipation
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2016201720182019
- Ph 4Terminated
A Study of the Effect of Linaclotide on Abdominal Girth in Participants With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT0283778321 Dec 2016 to 31 Oct 2018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The objective of this trial is to determine the effect of linaclotide on abdominal girth in IBS-C participants with the baseline symptoms of abdominal bloating and an increased abdominal girth.
Interventions
- LinaclotideDrug
- PlaceboDrug
Arms2
Experimental
290 μg linaclotide
Linaclotide Oral, once daily
Placebo comparator
Matching Placebo
Matching Placebo Oral, once daily
Primary outcomes1
Outcomes the sponsor listed as primary.
Change From Baseline in Abdominal Girth at Week 4
Time frame · Baseline, Week 4
Registry description
Mean change in abdominal girth (physical measure of bloating/distension) as measured by area under the curve (AUC), determined by 24-hour abdominal inductance plesthymography (AIP; with hourly averages). The AUC was calculated using the Trapezoidal method from the first reliable hour of measurement to last measurement (bedtime). The AUC for each participant was then individually standardized by dividing the total AUC over the period by that patient's number of hours of measurement included in the AUC. (Therefore, the time element was removed from the standardized AUC, and the unit of measure for this outcome is centimeters \[cm\]).
Secondary outcomes(9)
Change From Baseline in Abdominal Girth at Week 2
Time frame · Baseline, Week 2
Registry description
Mean change in abdominal girth (physical measure of bloating/distention) as measured by AUC, determined by 24-hour AIP (with hourly averages). The AUC was calculated using the Trapezoidal method from the first reliable hour of measurement to last measurement (bedtime). The AUC for each participant was then individually standardized by dividing the total AUC over the period by that patient's number of hours of measurement included in the AUC. (Therefore, the time element was removed from the standardized AUC, and the unit of measure for this outcome is centimeters \[cm\]).
Percent Change From Baseline in Maximal Abdominal Girth at Week 4
Time frame · Baseline, Week 4
Registry description
The maximum change in girth from the first hour, over the period from the 2nd hour to bedtime. The percentage change in maximum distension from baseline to 4 weeks will also be calculated.
Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 1
Time frame · Baseline, Week 1
Registry description
Symptom severity was assessed daily on an 11-point numerical rating scale (NRS) from 0 to 10, where 0 represents no symptoms and 10 represents very severe symptoms. Participants rated their abdominal pain, discomfort, bloating, and distension at its worst over the last 24 hours. Weekly average scores were calculated individually for abdominal pain, discomfort, bloating, distension. The abdominal score was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating combined. The abdominal score plus distension was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating and distension combined.
Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 2
Time frame · Baseline, Week 2
Registry description
Symptom severity was assessed daily on an 11-point NRS from 0 to 10, where 0 represents no symptoms and 10 represents very severe symptoms. Participants rated their abdominal pain, discomfort, bloating, and distension at its worst over the last 24 hours. Weekly average scores were calculated individually for abdominal pain, discomfort, bloating, distension. The abdominal score was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating combined. The abdominal score plus distension was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating and distension combined.
Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 3
Time frame · Baseline, Week 3
Registry description
Symptom severity was assessed daily on an 11-point NRS from 0 to 10, where 0 represents no symptoms and 10 represents very severe symptoms. Participants rated their abdominal pain, discomfort, bloating, and distension at its worst over the last 24 hours. Weekly average scores were calculated individually for abdominal pain, discomfort, bloating, distension. The abdominal score was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating combined. The abdominal score plus distension was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating and distension combined.
Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 4
Time frame · Baseline, Week 4
Registry description
Symptom severity was assessed daily on an 11-point NRS from 0 to 10, where 0 represents no symptoms and 10 represents very severe symptoms. Participants rated their abdominal pain, discomfort, bloating, and distension at its worst over the last 24 hours. Weekly average scores were calculated individually for abdominal pain, discomfort, bloating, distension. The abdominal score was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating combined. The abdominal score plus distension was calculated as the weekly average from the daily scores of the individual items of pain, discomfort, bloating and distension combined.
Change From Baseline in Digestive Sensations (Subjective Bloating, Abdominal Discomfort, Abdominal Distension and Abdominal Pain) at Week 2
Time frame · Baseline, Week 2
Registry description
A digestive sensations questionnaire was used to record abdominal pain, discomfort, bloating, and distension symptoms on an hourly basis (waking hours only) during the 24 hours the participants are fitted with the AIP belt, using an 11-point NRS, with 0=no symptomatic sensations and 10=most severe symptomatic sensations. Daily diary scores for each of the digestive symptoms was averaged to obtain 'weekly' scores.
Change From Baseline in Digestive Sensations (Subjective Bloating, Abdominal Discomfort, Abdominal Distension and Abdominal Pain) at Week 4
Time frame · Baseline, Week 4
Registry description
A digestive sensations questionnaire was used to record abdominal pain, discomfort, bloating, and distension on an hourly basis (waking hours only) during the 24 hours the participants are fitted with the AIP belt, using an 11-point NRS, with 0=no symptomatic sensations and 10=most severe symptomatic sensations. Daily diary scores for each of the digestive symptoms was averaged to obtain 'weekly' scores.
Change From Baseline in Bristol Stool Form Scale (BSFS) Over Time
Time frame · Baseline, Week 1, Week 2, Week 3, Week 4
Registry description
Daily stool consistency analyses were performed using the 7-point Bristol Stool Form Scale (BSFS), whereby a score of 1 = separate hard lumps like nuts (difficult to pass); 2 = sausage shaped but lumpy; 3 = like a sausage but with cracks on surface; 4 = like a sausage or snake, smooth and soft; 5 = soft blobs with clear-cut edges (passed easily); 6 = fluffy pieces with ragged edges, a mushy stool; and 7 = watery, no solid pieces (entirely liquid). Daily average recorded BSFS scores for each participant were computed for each week.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· Baseline, Week 2
Change From Baseline in Abdominal Girth at Week 2
| Group | Value (cm) | Spread |
|---|---|---|
| Matching Placebo | 0.535 | 9.15 |
| 290 μg Linaclotide | -2.3 | 13.7 |
Secondary outcomeMean· Baseline, Week 4
Percent Change From Baseline in Maximal Abdominal Girth at Week 4
| Group | Value (percent change) | Spread |
|---|---|---|
| Matching Placebo | -7.13 | 33.4 |
| 290 μg Linaclotide | 15.4 | 80.3 |
Secondary outcomeMean· Baseline, Week 1
Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 1
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Matching Placebo | -1.25 | 1.76 |
| 290 μg Linaclotide | -0.75 | 1.88 |
Secondary outcomeMean· Baseline, Week 2
Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 2
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Matching Placebo | -1.97 | 1.60 |
| 290 μg Linaclotide | -1.42 | 1.88 |
Secondary outcomeMean· Baseline, Week 3
Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 3
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Matching Placebo | -1.60 | 2.66 |
| 290 μg Linaclotide | -2.07 | 1.88 |
Secondary outcomeMean· Baseline, Week 4
Change From Baseline of Symptom Severity (Abdominal Pain, Discomfort, Bloating, and Distension) at Week 4
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Matching Placebo | -1.71 | 2.44 |
| 290 μg Linaclotide | -1.90 | 1.50 |
Secondary outcomeMean· Baseline, Week 2
Change From Baseline in Digestive Sensations (Subjective Bloating, Abdominal Discomfort, Abdominal Distension and Abdominal Pain) at Week 2
| Group | Value (units on a scale) | Spread |
|---|---|---|
| Matching Placebo | -1.13 | 1.38 |
| 290 μg Linaclotide | -0.61 | 1.10 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Matching PlaceboPlacebo once daily for 4 weeks | 0 / 9 | 1 / 9 | 1 / 9 |
| 290 μg Linaclotide290 μg linaclotide once daily for 4 weeks | 0 / 10 | 0 / 10 | 7 / 10 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
• Patient meets protocol criteria for diagnosis of IBS-C, abdominal pain, abdominal bloating and abdominal girth
Exclusion Criteria:
* Patient has history of loose or watery stools
* Patient has both clinically significant findings and unexplained clinically significant alarm symptoms
* Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
* Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
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