Trial · NCT00964496
Long-term Effects of Thalidomide for Recurrent Gastrointestinal Bleeding Due to Vascular Malformation
NCT00964496, Phase 2, Completed, Shanghai Jiao Tong University School of Medicine; results first posted 2010-04-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-term Effects of Thalidomide for Recurrent Gastrointestinal Bleeding Due to Vascular Malformation. Trials, record NCT00964496. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00964496
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Effects of Thalidomide for Recurrent Gastrointestinal Bleeding Due to Vascular Malformation
- NCT number
- NCT00964496
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 55 participants, actual
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Conditions
- Obscure Gastrointestinal Bleeding, Angiodysplasia, Gastric Antral Vascular Ectasia, Thalidomide
- Interventions
- Thalidomide, Iron
- First posted
- 2009-08-25
- Last updated
- 2015-12-17
- Results first posted
- 2010-04-30
- Limitations and caveats
Single center, open-label study; lack of placebo pills, make it impossible on equality of dosages between two groups; lack of dose response assessment either in patients or assays of serum vascular endothelial growth factor.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants Whose Rebleeds Decreased From Baseline by ≥ 50% at 12 Months | baseline and 12 months | The primary end point was defined as the patients whose rebleeds decreased from baseline by ≥ 50% at 12 months. Reduction of rebleeds = \[(total bleeding episode at 12 months - total bleeding episodes at a year before randomization)/total bleeding episodes at a year before randomization(baseline)\]\*100%. Rebleeding was defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment. |
| Primary | Cessation of Bleeding | 52 months | The cessation of bleeding was defined as repeated negative faecal occult blood test (FOBT) (monoclonal colloidal gold color technology) during our observation period. Rebleeding was defined based on a positive FOBT at any visit after treatment. |
| Secondary | Change From Baseline in Hemoglobin (Hb) Level at 12 Months | baseline and 12 months | The change from baseline in average hemoglobin (Hb) level(tested every month) at 12 months. |
| Secondary | Change From Baseline in Bleeding Episodes at 12 Months | baseline and 12 months | The Change from baseline in bleeding episodes at 12 months |
| Secondary | Change From Baseline in Bleeding Duration at 12 Months | baseline and 12 months | The change from baseline in bleeding duration at 12 months |
| Secondary | Participants Dependent on Blood Transfusions | 52 months | Numbers of participants dependent on blood transfusions |
| Secondary | Change From Baseline in Total Transfused Red Cell Requirements at 12 Months | baseline and 12 months | Change of total transfused red cell requirements at 12 months after randomization from one year before baseline in transfusion dependent patients |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants Whose Rebleeds Decreased From Baseline by ≥ 50% at 12 Months | baseline and 12 months | participants | NUMBER | |
| SECONDARY | Change From Baseline in Hemoglobin (Hb) Level at 12 Months | baseline and 12 months | g/L | MEAN | |
| SECONDARY | Change From Baseline in Bleeding Episodes at 12 Months | baseline and 12 months | bleeding episodes | MEAN | |
| SECONDARY | Change From Baseline in Bleeding Duration at 12 Months | baseline and 12 months | days | MEAN | |
| SECONDARY | Participants Dependent on Blood Transfusions | 52 months | 55 patients were enrolled in our study. One in iron-controlled group refused to continue for personal reason after 8 months, two other in thalidomide plus iron group refused to take study medications after 4 weeks treatment due to leukopenia and unexplained somnolence. Analysis was performed according to Intention-to-Treat principle. | participants | NUMBER |
| SECONDARY | Change From Baseline in Total Transfused Red Cell Requirements at 12 Months | baseline and 12 months | There are 14 participants depended on blood transfusion in each group | milliliter | MEAN |
| PRIMARY | Cessation of Bleeding | 52 months | participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants Whose Rebleeds Decreased From Baseline by ≥ 50% at 12 Months | Thalidomide Group | 20 | participants | ||
| Participants Whose Rebleeds Decreased From Baseline by ≥ 50% at 12 Months | Iron-controlled Group | 1 | participants | ||
| Change From Baseline in Hemoglobin (Hb) Level at 12 Months | Thalidomide Group | 3.06 | Standard Deviation 2.08 | g/L | |
| Change From Baseline in Hemoglobin (Hb) Level at 12 Months | Iron-controlled Group | -0.01 | Standard Deviation 1.32 | g/L | |
| Change From Baseline in Bleeding Episodes at 12 Months | Thalidomide Group | -9.36 | Standard Deviation 4.31 | bleeding episodes | |
| Change From Baseline in Bleeding Episodes at 12 Months | Iron-controlled Group | 1.41 | Standard Deviation 2.74 | bleeding episodes | |
| Change From Baseline in Bleeding Duration at 12 Months | Thalidomide Group | 5.2 | Standard Deviation 3.0 | days | |
| Change From Baseline in Bleeding Duration at 12 Months | Iron-controlled Group | 0.8 | Standard Deviation 5.1 | days | |
| Participants Dependent on Blood Transfusions | Thalidomide Group | 3 | participants | ||
| Participants Dependent on Blood Transfusions | Iron-controlled Group | 13 | participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Thalidomide Group | 28 | |
| Overall Study | STARTED | Iron-controlled Group | 27 | |
| Overall Study | COMPLETED | Thalidomide Group | 26 | |
| Overall Study | COMPLETED | Iron-controlled Group | 26 | |
| Overall Study | NOT COMPLETED | Thalidomide Group | 2 | |
| Overall Study | NOT COMPLETED | Iron-controlled Group | 1 |
Source ClinicalTrials.gov
Adverse events50
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 | Abdominal distension | Gastrointestinal disorders | Thalidomide Group | 1 | 28 | 9 |
| other | Abdominal distension | Gastrointestinal disorders | Iron-controlled Group | 1 | 27 | 12 |
| other | Abdominal pain | Gastrointestinal disorders | Thalidomide Group | 0 | 28 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Iron-controlled Group | 1 | 27 | 7 |
| other | Bitter taste | Gastrointestinal disorders | Thalidomide Group | 2 | 28 | 10 |
| other | Bitter taste | Gastrointestinal disorders | Iron-controlled Group | 0 | 27 | 0 |
| other | Blurred vision | Eye disorders | Thalidomide Group | 1 | 28 | 5 |
| other | Blurred vision | Eye disorders | Iron-controlled Group | 0 | 27 | 0 |
| other | Bradycardia | Cardiac disorders | Thalidomide Group | 1 | 28 | 1 |
| other | Bradycardia | Cardiac disorders | Iron-controlled Group | 0 | 27 | 0 |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Thalidomide Group | ||
| Total, all-cause mortality | Iron-controlled Group | ||
| Total, other adverse events | Thalidomide Group | 20 | 28 |
| Total, other adverse events | Iron-controlled Group | 9 | 27 |
| Total, serious adverse events | Thalidomide Group | 0 | 28 |
| Total, serious adverse events | Iron-controlled Group | 0 | 27 |
Source ClinicalTrials.gov
Papers3
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Thalidomide Group vs Iron-controlled Group: Cessation of Bleeding | Trial comparisons |
| Thalidomide Group vs Iron-controlled Group: Participants Dependent on Blood Transfusions | Trial comparisons |
| Thalidomide Group vs Iron-controlled Group: Participants Whose Rebleeds Decreased From Baseline by ≥ 50% at 12 Months | Trial comparisons |
| Thalidomide Group vs Iron-controlled Group: serious adverse events | Trial comparisons |
Tests0
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/NCT00964496
GET https://conductscience.org/api/trials/v1/NCT00964496/events?page=2