A Phase III Trial to Evaluate the Safety and Efficacy of Anti-inflammatory Drugs in Addition to Praziquantel in Girls and Women With Female Genital Schistosomiasis
NCT07915518, Phase 3, Not yet recruiting, Brian Ngwira
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Phase III Trial to Evaluate the Safety and Efficacy of Anti-inflammatory Drugs in Addition to Praziquantel in Girls and Women With Female Genital Schistosomiasis | ClinicalTrials.gov |
| NCT number | NCT07915518 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 800 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Brian Ngwira | ClinicalTrials.gov |
| Conditions | Female Genital Schistosomiasis | ClinicalTrials.gov |
| Interventions | Praziquantel 80, Prednisolone, Diclofenac, Diclofenac, Diclofenac given with Praziquantel 80mg (High dose), Prednisolone given with Praziquantel 80mg (High dose), 15d Diclofenac given with Praziquantel 80mg (High dose) | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Improvement in pathognomonic sign(s) in the cervix from baseline to month 3. | 3 months | Improvement in pathognomonic sign(s) in the cervix from baseline to month 3 (binary outcome of improvement vs no improvement) from cervical assessments only using Female Genital Schistosomiasis lesion indicators; grainy sandy patches, homogenous yellow patches and rubbery papules. | ClinicalTrials.gov |
| Primary | Improvement (reduction) in urogenital frequency symptom score from baseline to month 3. | 3 months | Improvement (reduction) in urogenital (gynaecological) frequency symptom score on a 0-4 scale, calculated as sum total of eight symptom components; lower abdominal pain, dysuria, vulvovaginal itching, abnormal vaginal discharge, menstrual disturbances, intermenstrual bleeding, dyspareunia and bleeding during or after intercourse, from baseline to month 3 (continuous outcome). Higher scores will indicate greater symptom burden. | ClinicalTrials.gov |
| Secondary | Effect of anti-inflammatory and Praziquantel dose on overall clinical improvement in women with FGS | 12 months | Assessing improvement in pathognomonic sign(s) in the cervix by FGS lesion indicators and urogenital (gynaecological) overall symptom score from baseline to months 3 (PZQ dose comparison only), 6 and 12. | ClinicalTrials.gov |
| Secondary | Effect of anti-inflammatory and Praziquantel dose on parasitological improvement in women with Female Genital Schistosomiasis. | 12 months | Assessed by measuring; Antigen (Circulating Anodic Antigen) concentration in urine at day 28, day 56 and month 3, 6, 12, total egg count by urine filtration at days 28 and 56 and months 3, 6, 12, and the absence of schistosome DNA in cervicovaginal swabs at months 3, 6, 12. | ClinicalTrials.gov |
| Secondary | Safety and tolerability of anti-inflammatory and Praziquantel treatment in women with Female Genital Schistosomiasis | 12 months | Assessing the safety and tolerability of trial treatments by occurrence of treatment emergent adverse events (TEAE) in all arms categorized as; non-serious TEAEs up to day 57, serious adverse events (SAEs) up to day 57, TEAE leading to discontinuation of treatment up to day 57, TEAE leading to trial withdrawal up to day 57, Fatal SAE up to month 12, and TEAE reported as related to trial drugs up to month 12. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)