| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00421707 | Randomized Placebo Controlled Efficacy And Safety Study Investigating GW876008 In Patients With Irritable Bowel Syndrome | PHASE2 | COMPLETED | 133 | — | — | Oct 14, 2006 | Jun 25, 2008 | Jan 31, 2018 | 23 | United States, Canada |
For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question 'In the past seven days have you had adequate relief of your IBS pain or discomfort? However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.
For the assessment of changes in weekly adequate relief rates during the treatment periods was planned by collecting the response of a question. Overall response was defined as having achieved adequate relief in last 4 weeks. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.
For the assessment of average adequate relief rate from IBS symptoms for a participant was planned by collecting the response of a question whether weekly adequate relief from IBS symptoms was achieved?. However, in error, the question was not collected in the IVRS system. Therefore, data for this endpoints was not collected during this study.
The GIS is comprised of ten questions, all rated on a seven point scale ranging from substantially worse (7) to substantially improved (1). GIS assesses the participant's improvement (or worsening) as assessed by the clinician on a 7-point scale: 1: very much improved; 2: much improved; 3: minimally improved; 4: no change; 5: minimally worse; 6: much worse; or 7: very much worse for diarrhea, constipation, stool frequency, stool consistency, urgency, bloating, incomplete evacuation, and straining. Values reported are less than the minimum score on scale as the rate is the proportion of the last four weeks that the participant is a responder.
The IBSQoL is a self-report quality-of-life measure specific to IBS that can be used to assess the impact of IBS and its treatment. The IBSQoL consists of 30 statements about bowel problems, which formed 9 scales: emotional health, mental health, health belief, sleep, energy, physical functioning, diet, social role, physical role and sexual relation. All 9 scales were rated on a five-point response scale ranging from 1 (always) to 5 (never). Scores for individual items were averaged to obtain a total score for each subscale of IBSQoL. Then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS-specific quality of life. Transformed scale score = (raw score - lowest possible scale score)/ (scale range) X 100. The data presented for individual scale.
| Arm | Type | Description |
|---|---|---|
| GW876008 | EXPERIMENTAL | GW876008 |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| GW876008 | DRUG | - |
| Placebo | OTHER | - |
Inclusion Criteria: * The subject has been diagnosed with IBS consistent with the Rome II Criteria as adapted in Appendix 3 of the protocol * The subject has normal results from a flexible sigmoidoscopy, colonoscopy, or a flexible sigmoidoscopy plus barium enema, according to subject's age, within ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Ardelyx, Inc. | ARDX | 4 | PHASE3 | Tenapanor |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Eluxadoline |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | — | Undisclosed |
| Johnson & Johnson | JNJ | 1 | — | Anti TNF therapy including infliximab, No Biologics |
| Cooper Companies, Inc. | COO | 1 | NA | Undisclosed |