Trial · NCT01903252
TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC)
NCT01903252, Phase 3, Completed, Tillotts Pharma AG; results first posted 2018-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC). Trials, record NCT01903252. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01903252
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC)
- NCT number
- NCT01903252
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 817 participants, actual
- Lead sponsor
- Tillotts Pharma AG
- Conditions
- Acute Ulcerative Colitis
- Interventions
- TP05, Asacol 400 mg
- First posted
- 2013-07-19
- Last updated
- 2018-08-08
- Results first posted
- 2018-08-08
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Period 1: Clinical and Endoscopic Remission | Week 8 | Mayo Score of \<= 2 points with no individual sub-score \> 1 |
| Primary | Period 2: Clinical Response, Open-Label Extended Induction | Week 16 | A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0. |
| Primary | Period 3: Clinical Remission | Week 38 | Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS) |
| Secondary | Period 1: Endoscopic Remission | Week 8 | Endoscopic remission was defined as a Mayo endoscopy subscore of 0 |
| Secondary | Period 1: Endoscopic Response | Week 8 | Endoscopic response was define as a reduction in the Mayo endoscopic sub score of at least one. |
| Secondary | Period 1: Clinical Remission | Week 8 | Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS) |
| Secondary | Period 1: Rectal Bleeding Sub-score of 0 | Week 8 | Rectal bleeding sub-score of 0 was defined as a sub score on the rectal bleeding component of the Mayo score |
| Secondary | Period 1: Clinical and Endoscopic Response | Week 8 | Clinical and Endoscopic Response was defined as a decrease in the Mayo score of ≥3 points from baseline and a reduction of ≥ 30% from baseline with either an accompanying decrease in the rectal bleeding sub-score of at least 1 point or an absolute rectal bleeding sub-score of 0 or 1 at the Week 8 visit. If a subject withdrew from the study prior to Week 8 or their response status was not evaluable due to incomplete and/or invalid data, the subject was considered a non-responder. |
| Secondary | Period 1: Clinical Remission | Week 12 | Clinical Remission was defined as a score of 0 points for both stool frequency and rectal bleeding on the Partial Mayo Clinic Score (PMCS) |
| Secondary | Period 1: Clinical Response | Week 12 | A decrease in the PMCS of ≥ 2 points and ≥ 30% from baseline, with a decrease in the rectal bleeding sub-score of ≥ 1 point or absolute rectal bleeding sub-score of 1 or 0. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Period 1: Clinical and Endoscopic Remission | Week 8 | Per Protocol | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Period 2: Clinical Response, Open-Label Extended Induction | Week 16 | Intent to Treat | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Period 3: Clinical Remission | Week 38 | Intent to Treat | percentage of participant | NUMBER |
| SECONDARY | Period 1: Endoscopic Remission | Week 8 | Per Protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Period 1: Endoscopic Response | Week 8 | Per Protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Period 1: Clinical Remission | Week 8 | Per Protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Period 1: Rectal Bleeding Sub-score of 0 | Week 8 | Per Protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Period 1: Clinical and Endoscopic Response | Week 8 | Per Protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Period 1: Clinical Remission | Week 12 | Per Protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Period 1: Clinical Response | Week 12 | Per protocol | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Period 1: Clinical and Endoscopic Remission | TP05 (Mesalazine) | 87 | Participants | ||
| Period 1: Clinical and Endoscopic Remission | Asacol (Mesalazine, Tillotts Pharma AG) | 95 | Participants | ||
| Period 2: Clinical Response, Open-Label Extended Induction | Extended Induction | 183 | Participants | ||
| Period 3: Clinical Remission | 1.6g/Day Maintenance Open-Label | 70.3 | percentage of participant | ||
| Period 3: Clinical Remission | 3.2/Day Maintenance Open-Label | 33.9 | percentage of participant | ||
| Period 3: Clinical Remission | 4.8g/Day Maintenance Open-Label | 30.7 | percentage of participant | ||
| Period 1: Endoscopic Remission | TP05 (Mesalazine) | 36 | Participants | ||
| Period 1: Endoscopic Remission | Asacol (Mesalazine, Tillotts Pharma AG) | 44 | Participants | ||
| Period 1: Endoscopic Response | TP05 (Mesalazine) | 185 | Participants | ||
| Period 1: Endoscopic Response | Asacol (Mesalazine, Tillotts Pharma AG) | 196 | Participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Induction | STARTED | TP05 (Mesalazine) 1600 mg | 409 | |
| Double-Blind Induction | STARTED | Asacol (Mesalazine 400 mg) | 408 | |
| Double-Blind Induction | STARTED | Extended Induction | 0 | |
| Double-Blind Induction | STARTED | 1.6g TP05 (1600 mg) /Day Maintenance Open-Label | 0 | |
| Double-Blind Induction | STARTED | 3.2g TP05 (1600 mg) /Day Maintenance Open-Label | 0 | |
| Double-Blind Induction | STARTED | 4.8g TP05 (1600 mg) /Day Maintenance Open-Label | 0 | |
| Double-Blind Induction | COMPLETED | TP05 (Mesalazine) 1600 mg | 370 | |
| Double-Blind Induction | COMPLETED | Asacol (Mesalazine 400 mg) | 367 | |
| Double-Blind Induction | COMPLETED | Extended Induction | 0 | |
| Double-Blind Induction | COMPLETED | 1.6g TP05 (1600 mg) /Day Maintenance Open-Label | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events130
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Worsening of UC | Gastrointestinal disorders | TP05/TP05 | 58 | 409 | 59 |
| other | Worsening of UC | Gastrointestinal disorders | Asacol/TP05 | 75 | 408 | 75 |
| other | Worsening of UC | Gastrointestinal disorders | TP05 Extended Induction | 0 | 243 | 0 |
| other | Worsening of UC | Gastrointestinal disorders | TP05 | 26 | 409 | 27 |
| other | Worsening of UC | Gastrointestinal disorders | Asacol | 22 | 408 | 22 |
| serious | Deterioration ulcerative colities | Gastrointestinal disorders | TP05/TP05 | 9 | 409 | 10 |
| serious | Deterioration ulcerative colities | Gastrointestinal disorders | Asacol/TP05 | 6 | 408 | 7 |
| serious | Deterioration ulcerative colities | Gastrointestinal disorders | TP05 Extended Induction | 0 | 243 | 0 |
| serious | Deterioration ulcerative colities | Gastrointestinal disorders | TP05 | 4 | 409 | 5 |
| serious | Deterioration ulcerative colities | Gastrointestinal disorders | Asacol | 4 | 408 | 4 |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TP05/TP05 | ||
| Total, all-cause mortality | Asacol/TP05 | ||
| Total, all-cause mortality | TP05 Extended Induction | ||
| Total, all-cause mortality | TP05 | ||
| Total, all-cause mortality | Asacol | ||
| Total, other adverse events | TP05/TP05 | 58 | 409 |
| Total, other adverse events | Asacol/TP05 | 75 | 408 |
| Total, other adverse events | TP05 Extended Induction | 0 | 243 |
| Total, other adverse events | TP05 | 26 | 409 |
| Total, other adverse events | Asacol | 22 | 408 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TP05 (Mesalazine) vs Asacol (Mesalazine, Tillotts Pharma AG): Period 1: Rectal Bleeding Sub-score of 0 | Trial comparisons |
| TP05 (Mesalazine) vs Asacol (Mesalazine, Tillotts Pharma AG): Period 1: Clinical Remission at Both Week 8 and 12 | Trial comparisons |
| TP05 (Mesalazine) vs Asacol (Mesalazine, Tillotts Pharma AG): Period 1: Clinical Remission | Trial comparisons |
| TP05 (Mesalazine) vs Asacol (Mesalazine, Tillotts Pharma AG): Period 1: Clinical and Endoscopic Remission | Trial comparisons |
| TP05 (Mesalazine) vs Asacol (Mesalazine, Tillotts Pharma AG): Period 1: Clinical Response | Trial comparisons |
| TP05 (Mesalazine) vs Asacol (Mesalazine, Tillotts Pharma AG): Period 1: Clinical Response at Both Week 8 and Week 12 | Trial comparisons |
| TP05 (Mesalazine) vs Asacol (Mesalazine, Tillotts Pharma AG): Period 1: Clinical Remission | Trial comparisons |
| TP05 (Mesalazine) vs Asacol (Mesalazine, Tillotts Pharma AG): Period 1: Endoscopic Response | Trial comparisons |
| TP05 (Mesalazine) vs Asacol (Mesalazine, Tillotts Pharma AG): Period 1: Rectal Bleeding Score of 0 | Trial comparisons |
| TP05 (Mesalazine) vs Asacol (Mesalazine, Tillotts Pharma AG): Period 1: Endoscopic Remission | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01903252
GET https://conductscience.org/api/trials/v1/NCT01903252/registered?page=2