Trial · NCT01678313
Cyclooxygenase-2 (COX-2) Inhibitor Reduces Serum Prostatic Specific Antigen (PSA) Levels
NCT01678313, Phase 2, Completed, Buddhist Tzu Chi General Hospital; results first posted 2014-06-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cyclooxygenase-2 (COX-2) Inhibitor Reduces Serum Prostatic Specific Antigen (PSA) Levels. Trials, record NCT01678313. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01678313
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cyclooxygenase-2 (COX-2) Inhibitor Reduces Serum Prostatic Specific Antigen (PSA) Levels
- NCT number
- NCT01678313
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 140 participants, actual
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Conditions
- Benign Prostatic Hyperplasia
- Interventions
- Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD), Doxazosin 4 mg every day (QD)
- First posted
- 2012-09-05
- Last updated
- 2014-07-15
- Results first posted
- 2014-06-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level | Baseline and 3 months after initial treatment | Efficacy: Change from Baseline in the serum PSA level from baseline and 3 months Change = Month 3 minus Baseline value |
| Secondary | Change From Baseline in the Void Volume (VV) | Baseline and 3 months after initial treatment | Efficacy: Change from Baseline in the Void Volume (VV) from baseline and 3 months Change = Month 3 minus Baseline value |
| Secondary | Change From Baseline in the Maximum Flow Rate (Qmax) | Baseline and 3 months after initial treatment | Efficacy: Change from Baseline in the maximum flow rate (Qmax) from baseline and 3 months Change = Month 3 minus Baseline value |
| Secondary | Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires | Baseline and 3 months after initial treatment | Efficacy: Change from Baseline in the IPSS Voiding from baseline and 3 months. The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic). Change = Month 3 minus Baseline value |
| Secondary | Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires | Baseline and 3 months after initial treatment | Efficacy: Change from Baseline in the IPSS Storage from baseline and 3 months The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic). Change = Month 3 minus Baseline value |
| Secondary | Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires | Baseline and 3 months after initial treatment | Efficacy: Change from Baseline in the International Prostate Symptom Score (IPSS) from baseline and 3 months The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS Voiding), 3 storage questions (IPSS Storage) The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Total IPSS score = IPSS voiding + IPSS Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35 Change = Month 3 minus Baseline value |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level | Baseline and 3 months after initial treatment | ng/mL | MEAN | |
| SECONDARY | Change From Baseline in the Void Volume (VV) | Baseline and 3 months after initial treatment | mL | MEAN | |
| SECONDARY | Change From Baseline in the Maximum Flow Rate (Qmax) | Baseline and 3 months after initial treatment | mL/s | MEAN | |
| SECONDARY | Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires | Baseline and 3 months after initial treatment | units on a scale | MEAN | |
| SECONDARY | Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires | Baseline and 3 months after initial treatment | units on a scale | MEAN | |
| SECONDARY | Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires | Baseline and 3 months after initial treatment | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level | Study Group | Baseline | 10.8 | Standard Deviation 5.42 | ng/mL |
| Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level | Control Group | Baseline | 15.2 | Standard Deviation 12.7 | ng/mL |
| Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level | Study Group | 3 months | 9.42 | Standard Deviation 5.41 | ng/mL |
| Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level | Control Group | 3 months | 13.5 | Standard Deviation 10.6 | ng/mL |
| Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level | Study Group | Change | -1.43 | Standard Deviation 0.01 | ng/mL |
| Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level | Control Group | Change | -1.70 | Standard Deviation 2.15 | ng/mL |
| Change From Baseline in the Void Volume (VV) | Study Group | Baseline | 259 | Standard Deviation 113 | mL |
| Change From Baseline in the Void Volume (VV) | Control Group | Baseline | 175 | Standard Deviation 107 | mL |
| Change From Baseline in the Void Volume (VV) | Study Group | 3 months | 227 | Standard Deviation 80.8 | mL |
| Change From Baseline in the Void Volume (VV) | Control Group | 3 months | 231 | Standard Deviation 134 | mL |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Completed the 3-month Therapy | STARTED | Study Group | 70 | |
| Completed the 3-month Therapy | STARTED | Control Group | 70 | |
| Completed the 3-month Therapy | COMPLETED | Study Group | 64 | |
| Completed the 3-month Therapy | COMPLETED | Control Group | 58 | |
| Completed the 3-month Therapy | NOT COMPLETED | Study Group | 6 | |
| Completed the 3-month Therapy | NOT COMPLETED | Control Group | 12 | |
| PSA >4 ng/dL at 3 Months | STARTED | Study Group | 64 | |
| PSA >4 ng/dL at 3 Months | STARTED | Control Group | 58 | |
| PSA >4 ng/dL at 3 Months | COMPLETED | Study Group | 56 | |
| PSA >4 ng/dL at 3 Months | COMPLETED | Control Group | 49 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Study Group | ||
| Total, all-cause mortality | Control Group | ||
| Total, other adverse events | Study Group | 0 | 64 |
| Total, other adverse events | Control Group | 0 | 58 |
| Total, serious adverse events | Study Group | 0 | 64 |
| Total, serious adverse events | Control Group | 0 | 58 |
Source ClinicalTrials.gov
Papers13
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Study Group vs Control Group: serious adverse events |
Source 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/NCT01678313
GET https://conductscience.org/api/trials/v1/NCT01678313/results?page=2